510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2021
DEVICE: Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
Maxstar Industrial Co., Ltd. 510(k) NO: K191441(Traditional)
ATTN: Jonghwa Lim PHONE NO : 82 31 9893543
152 - 12 Hwanggeum-ro 23beon-gil, SE DECISION MADE: 05-MAR-21
Gimpo KR 415843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endo Motor
Foshan CICADA Dental Instrument Co510(k) NO: K192649(Traditional)
ATTN: Juan Liu PHONE NO : 86 757 85775667
B5-2F, Guangdong New Light Source SE DECISION MADE: 12-MAR-21
Nanhai District, Foshan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIDA Wearable Neuromodulation System
Exodus Innovations 510(k) NO: K192731(Traditional)
ATTN: Isaac Oppenheim PHONE NO : 347 9540624
1 Exodus Road SE DECISION MADE: 19-MAR-21
Sufa IL 85457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FloPump 57mL Centrifugal Pump
International Biophysics Corporati510(k) NO: K193663(Traditional)
ATTN: Geoff Marcek PHONE NO : 512 8140046
2101 E. St. Elmo Road SE DECISION MADE: 10-MAR-21
Austin TX 78744 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Low-frequency Multi-function physiotherapy instrument
Shenzhen Kentro Medical Electronic510(k) NO: K200177(Traditional)
ATTN: Zewu Zhang PHONE NO : 86 755 33825998
No.3, Xihu industry zone, Xikeng VSE DECISION MADE: 25-MAR-21
Longgang District,Shenzhen City C510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Myriad Particles
Aroa Biosurgery Ltd. 510(k) NO: K200502(Traditional)
ATTN: Tina O'Brien PHONE NO : 64 09 8693035
2 Kingsford Smith Place SE DECISION MADE: 31-MAR-21
Airport Oaks NZ 2022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LumiCare Caries Diagnostic Rinse
GreenMark Biomedical Inc. 510(k) NO: K200601(Third Party - Traditional)
ATTN: Steven Bloembergen PHONE NO : 517 8963665
325 E. Grand River Ave., Suite 314SE DECISION MADE: 29-MAR-21
East Lansing MI 48823 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Compressible Limb and Circulation Therapy System
Wonjin Mulsan Co., Ltd 510(k) NO: K200660(Traditional)
ATTN: Ha Yong Jung PHONE NO : 82 32 8160552
Seo-gu SE DECISION MADE: 08-MAR-21
Incheon KR 22653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarus Peel-Away Introducer Sheath
Clarus Medical, LLC 510(k) NO: K200925(Traditional)
ATTN: Mark F. Brown PHONE NO : 763 5258445
13355 10th Ave N Suite 110 SE DECISION MADE: 18-MAR-21
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modulith SLX-F2
KARL STORZ Endoscopy America 510(k) NO: K201001(Traditional)
ATTN: Winkie Wong PHONE NO : 424 2188379
2151 E Grand Avenue SE DECISION MADE: 30-MAR-21
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sovereign America Surgical Face Mask
HomTex, Inc. 510(k) NO: K201095(Abbreviated)
ATTN: Jeremy Wootten PHONE NO : 256 7343937
2125 2nd Avenue SW SE DECISION MADE: 19-MAR-21
Cullman AL 35055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruAbutment DS, TruBase S
TruAbutment Inc. 510(k) NO: K201197(Traditional)
ATTN: Eunjin Jang PHONE NO : 714 9561488
17742 Cowan SE DECISION MADE: 26-MAR-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode Evolve System with the Tone Applicator
InMode Ltd. 510(k) NO: K201285(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 05-MAR-21
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANAM Test System
Vista LifeSciences, Inc. 510(k) NO: K201376(Traditional)
ATTN: Margaret E. Molloy PHONE NO : 888 7338804 1
7375 S. Peoria St. Suite 210 SE DECISION MADE: 25-MAR-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENUS Bracket, ROSE Bracket
GNI Co., LTD 510(k) NO: K201410(Traditional)
ATTN: Duk Soo Kim PHONE NO : 82 505600 8880
5F 501, 63-12 DongtancheomdansaneoSE DECISION MADE: 12-MAR-21
Hwaseong KR 18469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Republic Spine Dark Star Spinal System
Republic Spine, LLC 510(k) NO: K201420(Traditional)
ATTN: James Doulgeris PHONE NO : 561 3342421
2424 N Federal Hwy, STE 257 SE DECISION MADE: 05-MAR-21
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arisure Closed System Drug Transfer Device (CSTD)
Yukon Medical, LLC 510(k) NO: K201422(Traditional)
ATTN: Pamela McNulty PHONE NO : 919 5958253
4021 Stirrup Creek Dr Ste 200 SE DECISION MADE: 02-MAR-21
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyCRO Band
Otto Bock Healthcare LP 510(k) NO: K201426(Traditional)
ATTN: Caleb Beck PHONE NO : 801 9746647
3820 West Great Lakes Drive SE DECISION MADE: 26-MAR-21
Salt Lake City UT 84120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Groshong NXT PICC Catheter
C.R. Bard, Inc. 510(k) NO: K201452(Traditional)
ATTN: Matthew Lyman PHONE NO : 801 5225416
605 North 5600 West SE DECISION MADE: 12-MAR-21
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tranberg CLS Laser Applicator
Clinical Laserthermia Systems, AB 510(k) NO: K201466(Traditional)
ATTN: Lars-Erik Eriksson PHONE NO : 46 461 52100
Scheelevägen 2 SE DECISION MADE: 26-MAR-21
Lund SE 22381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile Zirconia Block
Bioden Co., Ltd 510(k) NO: K201492(Traditional)
ATTN: MyeongEun Song PHONE NO : 82 2629 22840
#B-803 119, Gasan Digital 1-ro, GeSE DECISION MADE: 10-MAR-21
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Dongguan Prestige Sporting Goods C510(k) NO: K201508(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 1376 3128800
3rd Industrial, Qiaotou Area, HoujSE DECISION MADE: 09-MAR-21
Dongguan CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
AVINENT Implant System S.L.U. 510(k) NO: K201533(Traditional)
ATTN: Anna Cortina PHONE NO : 00 34 902383848
Pol. Ind. Santa Anna SE DECISION MADE: 01-MAR-21
Santpedor ES 08251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPR BAND
CREDO 510(k) NO: K201581(Traditional)
ATTN: Ji Hyo Wang PHONE NO : 82 33 7668901
#302, 86, Baeul-ro SE DECISION MADE: 06-MAR-21
Wonju-si KR 26465 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMMA Capnograph
Masimo Corporation 510(k) NO: K201590(Special)
ATTN: Katelynn Kirby PHONE NO : 949 2977000
52 Discovery SE DECISION MADE: 29-MAR-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
Schoelly Fiberoptic GmbH 510(k) NO: K201617(Traditional)
ATTN: Sandra Baumann PHONE NO : 0049 766 6908357
Robert-Bosch-Strasse 1-3 SE DECISION MADE: 12-MAR-21
Denzlingen DE 79211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spin Care Disposable Protective Mask
SpinTech LLC 510(k) NO: K201624(Traditional)
ATTN: Jim Jean PHONE NO : 704 9293596
1920 Flintstone Drive SE DECISION MADE: 18-MAR-21
Statesville NC 28677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Subcutaneous Infusion Set
Epic Medical Pte. Ltd. 510(k) NO: K201626(Traditional)
ATTN: Freddie Lee PHONE NO :
105 Cecil Street #20-04 The OctagoSE DECISION MADE: 24-MAR-21
Singapore SG 069534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RG 3ml Medication Cartridge
Chengdu Shifeng Medical Technology510(k) NO: K201634(Traditional)
ATTN: Nick Wang PHONE NO : 086 028 8245916
No. 31, Yinyuan Road SE DECISION MADE: 26-MAR-21
Jinhua Town, Xinjin County CN 611510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cultura Collection and Transport System
Merit Medical Systems, Inc 510(k) NO: K201674(Traditional)
ATTN: Alex Bohorquez PHONE NO : 801 2084685
1600 West Merit Parkway SE DECISION MADE: 03-MAR-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iCE-SG Subcutaneous Electrode Arrays
iCE Neurosystems, Inc. 510(k) NO: K201678(Traditional)
ATTN: Allen Waziri PHONE NO : 646 2509166
1875 Connecticut Ave NW, Suite 121SE DECISION MADE: 08-MAR-21
Washington DC 20009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask
Hangzhou Mycode Bio-Medicine Co., 510(k) NO: K201698(Traditional)
ATTN: Alice Gong PHONE NO : 86 571 87329869
Floor 4, Building No. 4, No. 2 XiySE DECISION MADE: 15-MAR-21
Hangzhou CN 310030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
Fisher & Paykel Healthcare Ltd. 510(k) NO: K201723(Traditional)
ATTN: Reena Daken PHONE NO : 64 5740100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 16-MAR-21
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AllerBlock Junior
Nasaleze International Ltd 510(k) NO: K201734(Traditional)
ATTN: Matt Duxbury PHONE NO : 44 0 1624611050
Old Castletown Road SE DECISION MADE: 26-MAR-21
Douglas IM Im2 1qa 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVision ICE Catheter
NuVera Medical, Inc. 510(k) NO: K201775(Traditional)
ATTN: Robert Nardelli PHONE NO : 951 9991230
140 Knowles Dr. SE DECISION MADE: 05-MAR-21
Los Gatos CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
Baxter Healthcare Corportation 510(k) NO: K201809(Traditional)
ATTN: Kristen Bozzelli PHONE NO : 224 9485585
25212 W. Illinois Route 120 SE DECISION MADE: 10-MAR-21
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask-Model Number: Ear Loop, Flat-Pleated
Huizhou Foryou Medical Devices Co.510(k) NO: K201852(Abbreviated)
ATTN: Guosheng Tan PHONE NO : 86 0752 5302185
No. 1 Shangxia North Road, DongjiaSE DECISION MADE: 02-MAR-21
Huizhou CN 516005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovaLine Tubing Sets for Hemodialysis
Bain Medical Equipment(Guangzhou) 510(k) NO: K201866(Traditional)
ATTN: Zoe Zeng PHONE NO : 86 20 66856868 290
No.10, Juncheng Road, Eastern AreaSE DECISION MADE: 10-MAR-21
Guangzhou CN 510760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST-Z5
Z-Systems AG 510(k) NO: K201878(Traditional)
ATTN: Rubino DiGirolamo PHONE NO : 41 62388 6969
Werkhofstrasse 5 SE DECISION MADE: 25-MAR-21
Oensingen CH ch-4702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Thermometer Model T103, T104
Bioland Technology Ltd. 510(k) NO: K201879(Traditional)
ATTN: Yiqing Feng PHONE NO : 86 755 36900999
No. A6B7 (Block G) ShangRong IndusSE DECISION MADE: 31-MAR-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ritleng®+ and Ritleng®+ PVP
FCI (France Chirurgie Instrumentat510(k) NO: K201892(Traditional)
ATTN: Thierry Fetick PHONE NO : 33 153 989898
20-22 rue Louis Armand SE DECISION MADE: 11-MAR-21
Paris FR 75015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
IOB Medical Inc 510(k) NO: K201896(Traditional)
ATTN: Jiulin Xia PHONE NO : 301 2500831
504E Diamond Ave., Suite I SE DECISION MADE: 30-MAR-21
Gaithersburg MD 20877 510(k) STATEMENT
DEVICE: Spacelabs Lifescreen PRO Analyzer
Spacelabs Healthcare Ltd. 510(k) NO: K201921(Traditional)
ATTN: Roger Moldon PHONE NO : 011 44 1992507730
Unit B, Foxholes Centre, John TateSE DECISION MADE: 26-MAR-21
Hertford GB SG13 7DT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Surgical Mask
Qiqihar Hengxin Medical Supplies, 510(k) NO: K201924(Traditional)
ATTN: Sihui Xiong PHONE NO : 86 452 5656959
10th Beijiang Road in Tiefang InduSE DECISION MADE: 15-MAR-21
Qiqihar CN 161000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Getinge GSS610N Series Steam Sterilizer
Maquet GmbH 510(k) NO: K201927(Traditional)
ATTN: Holger Ullrich PHONE NO : 49 722 29321550
Kehler Strasse 31 SE DECISION MADE: 01-MAR-21
Rastatt DE 76437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A8, A9 Anesthesia System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K201957(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81888998
Mindray Building, Keji 12th Road SSE DECISION MADE: 26-MAR-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
Chison Medical Technologies Co., L510(k) NO: K201965(Traditional)
ATTN: Qifei Liu PHONE NO : 0086 510 85311707
No.228, Changjiang East Road, BlocSE DECISION MADE: 02-MAR-21
Wuxi CN 214142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use medical face mask
Guangdong Horigen Mother & Baby Pr510(k) NO: K201974(Traditional)
ATTN: Jun Deng PHONE NO : 086 0754 83613668
Block A&B&C, NCBC Industrial Park,SE DECISION MADE: 07-MAR-21
Shantou CN 515100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: miha bodytec II
Miha Bodytec Gmbh 510(k) NO: K201975(Traditional)
ATTN: Felix Schweigert PHONE NO : 49 821 45549222
Siemensstr. 1 SE DECISION MADE: 11-MAR-21
Gersthofen DE 86368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air compression therapy system FO-3001; Air compression therapy system FO-3008
Foshan Hongfeng Co., Ltd 510(k) NO: K201982(Traditional)
ATTN: Cheng Dongfeng PHONE NO : 086 0757 8392028
No.4-2 Leqiang Road, Leping SanshuSE DECISION MADE: 25-MAR-21
Foshan CN 528000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026
Shenzhen Juzhong Technology Co., L510(k) NO: K202009(Traditional)
ATTN: Chang Lihua PHONE NO : 0086 755 27764799
Block B, floor 3, building 38, SanSE DECISION MADE: 22-MAR-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: White ENDOSEAL MTA
Maruchi 510(k) NO: K202015(Traditional)
ATTN: Sung Wook Jang PHONE NO : 82 33 7340330
2-208, Medical Industry Complex BlSE DECISION MADE: 24-MAR-21
Wonju-si KR 26311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
Hill-Rom, Inc. 510(k) NO: K202018(Traditional)
ATTN: Jigar Shah PHONE NO : 1 201 2841024
1069 State Route 46 East SE DECISION MADE: 04-MAR-21
Batesville IN 47006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: imani i2
imani Co. 510(k) NO: K202037(Traditional)
ATTN: Hyo-Soon Hwang PHONE NO : 82 31 3234435
1F, Na Dong, 19, Wanjangcheon-ro 3SE DECISION MADE: 01-MAR-21
Yongin-si KR 17117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: wheezo WheezeRate Detector
Respiri Limited 510(k) NO: K202062(Traditional)
ATTN: Samaneh Sarraf PHONE NO : 61 491 208783
Level 10, 446 Collins Street SE DECISION MADE: 11-MAR-21
Melbourne AU 3000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeedleSmart Professional (NS Pro)
NeedleSmart Limited 510(k) NO: K202073(Traditional)
ATTN: Tom Baker PHONE NO : 44 0151 3150516
Suite 2B, Stanley Grange Business SE DECISION MADE: 25-MAR-21
Knowsley, Prescot GB L34 5NB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
Shen Wei USA Inc. 510(k) NO: K202076(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 05-MAR-21
Union City CA 94587 510(k) STATEMENT
DEVICE: Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
Shen Wei USA Inc. 510(k) NO: K202078(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 05-MAR-21
Union City CA 94587 510(k) STATEMENT
DEVICE: Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
Shen Wei USA Inc. 510(k) NO: K202080(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 24-MAR-21
Union City CA 94587 510(k) STATEMENT
DEVICE: Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
Shen Wei USA Inc. 510(k) NO: K202081(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 19-MAR-21
Union City CA 94587 510(k) STATEMENT
DEVICE: Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
Shen Wei USA Inc. 510(k) NO: K202082(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 17-MAR-21
Union City CA 94587 510(k) STATEMENT
DEVICE: Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Shen Wei USA Inc. 510(k) NO: K202083(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 25-MAR-21
Union City CA 94587 510(k) STATEMENT
DEVICE: Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors
Shen Wei USA Inc. 510(k) NO: K202086(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 16-MAR-21
Union City CA 94587 510(k) STATEMENT
DEVICE: Ceragem Automatic Thermal Massager, Model CGM-MB-1901
Ceragem Co, Ltd. 510(k) NO: K202113(Traditional)
ATTN: Hyeonggeun Hwang PHONE NO :
10, Jeongja 1-Gil, Seonggeo-Eup, SSE DECISION MADE: 02-MAR-21
Cheonan-Si KR 31041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Century Perfusion System
Century HLM, LLC 510(k) NO: K202125(Traditional)
ATTN: Jeff Poland PHONE NO : 1 314 4975232
3110 N. Oakland, STE 101 SE DECISION MADE: 07-MAR-21
Mesa AZ 85215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Mask
Hangzhou Qianzhiya Sanitary Produc510(k) NO: K202133(Traditional)
ATTN: Yu Shao PHONE NO : 86 571 69910779
No.88 Fengwang Road, Economic DeveSE DECISION MADE: 25-MAR-21
Hangzhou CN 311500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable medical mask
U-Play Products Corporation 510(k) NO: K202137(Traditional)
ATTN: Jin Jing PHONE NO : 86 553 8516886
No.7, Fumin Road, Jiujiang EconomiSE DECISION MADE: 04-MAR-21
Wuhu CN 241000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Hunan EEXI Technology & Service Co510(k) NO: K202161(Traditional)
ATTN: Zhang Xianliang PHONE NO : 0086 1587 4115252
No.6 North of Pingtou Road, LiuyanSE DECISION MADE: 10-MAR-21
Liuyang CN 410300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senhance Surgical System
TransEnterix, Inc. 510(k) NO: K202166(Traditional)
ATTN: Kaitlyn Alexander PHONE NO : 1 919 7658400 8505
635 Davis Drive, Suite 300 SE DECISION MADE: 02-MAR-21
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueRelief Device
TrueRelief 510(k) NO: K202186(Traditional)
ATTN: John Crosson PHONE NO : 310 9189064
100 Wilshire Boulevard, Suite 700 SE DECISION MADE: 23-MAR-21
Santa Monica CA 90401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Wuhan Zonsen Medical Products Co.,510(k) NO: K202191(Traditional)
ATTN: Shirly Xi PHONE NO : 86 158 27495791
Chengbei Industry Zone, Zhucheng ASE DECISION MADE: 29-MAR-21
Wuhan CN 431000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Jiangsu Micsafe Medical Technology510(k) NO: K202205(Traditional)
ATTN: Tony Yang PHONE NO : 86 13 651929266
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 09-MAR-21
Yancheng CN 224125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFM Surgical Mask Model SM3
FSSC, LLC 510(k) NO: K202214(Third Party - Traditional)
ATTN: Clayton Geyer PHONE NO : 219 8638316
3300 West Clark St. SE DECISION MADE: 02-MAR-21
Rensselaer IN 47978 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Oncospace
Oncospace, Inc. 510(k) NO: K202284(Traditional)
ATTN: Praveen Sinha PHONE NO : 608 2396871
1812 Ashland Ave., Suite 100k SE DECISION MADE: 12-MAR-21
Baltimore MD 21205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
Optellum Ltd 510(k) NO: K202300(Traditional)
ATTN: David Arrowsmith PHONE NO : 44 7542 006599
Oxford Centre for Innovation, New SE DECISION MADE: 05-MAR-21
Oxford GB OX1 1BY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical mask (Model: KKF-1A)
Han Zhaoqing Sporting Goods Compan510(k) NO: K202316(Traditional)
ATTN: Zhang Ming PHONE NO : 86 138 25518595
NO.2-1, Kang tai Street, High-techSE DECISION MADE: 03-MAR-21
Zhaoqing CN 526238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
Kanglongda Vietnam Protection Tech510(k) NO: K202356(Traditional)
ATTN: Lu Lingfeng PHONE NO : 84 234 3888189
Lot CN 05, Viglacera-Phong Dien InSE DECISION MADE: 02-MAR-21
Phong Dien VN 535041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL Propaq M
ZOLL Medical Corporation 510(k) NO: K202375(Traditional)
ATTN: Elizabeth McMeniman PHONE NO : 978 5696862
269 Mill Road SE DECISION MADE: 09-MAR-21
Chelmsford MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invacare AVIVA Storm RX Power Chair
Invacare Corporation 510(k) NO: K202379(Traditional)
ATTN: Elijah Wreh PHONE NO : 440 3296840
One Invacare Way SE DECISION MADE: 19-MAR-21
Elyria OH 44035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves (Blue, Violet Blue, White)
Jiangsu Tianshuo Medical Products 510(k) NO: K202402(Traditional)
ATTN: Gao Feng PHONE NO : 86 152 03225200
No. 78, North Longjin Road, SuchenSE DECISION MADE: 01-MAR-21
SuQian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Allmed Medical Products Co., Ltd. 510(k) NO: K202409(Traditional)
ATTN: Vince Tian PHONE NO : 86 717 4211111
No. 99, Jin Shan Road, Majiadian TSE DECISION MADE: 09-MAR-21
Zhijiang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Allmed Medical Products Co., Ltd. 510(k) NO: K202411(Traditional)
ATTN: Vince Tian PHONE NO : 86 717 4211111
No. 99, Jin Shan Road, Majiadian TSE DECISION MADE: 10-MAR-21
Zhijiang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask-Models CR02-2, CR02
Foshan Xinbao Technology Co., Ltd.510(k) NO: K202424(Traditional)
ATTN: Weishan Peng PHONE NO : 86 1390 2839882
No. 20 Changjiang Road, Sanshan NeSE DECISION MADE: 31-MAR-21
Foshan CN 528251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ensure Single-Use Coagulation Forceps
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K202438(Traditional)
ATTN: Cecilia Sun PHONE NO : 86 25 58646395
No. 10 Gaoke Thrid Road SE DECISION MADE: 15-MAR-21
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask
Hunan EEXI Technology & Service Co510(k) NO: K202439(Traditional)
ATTN: Zhang Xianliang PHONE NO : 86 1587 4115252
No. 6 North of Pingtou Road, LiuyaSE DECISION MADE: 08-MAR-21
Liuyang CN 410300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Kit Basic, Smart Kit Pro
BSL Co., Ltd 510(k) NO: K202443(Traditional)
ATTN: Jun Seok Lee PHONE NO : 82 55 3289235
6-13, Chilsan-ro 237beon-gil SE DECISION MADE: 11-MAR-21
Gimhae-si KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
Safecare Biotech(Hangzhou)Co.,Ltd.510(k) NO: K202453(Traditional)
ATTN: Alex Qiu PHONE NO : 86 571 89712897
Building 2/203 No.18 Haishu Rd., CSE DECISION MADE: 24-MAR-21
Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y207 Electric Wheelchair
Jiangsu Intco Medical Products Co.510(k) NO: K202482(Traditional)
ATTN: Wang Maokun PHONE NO : 86 511 83174088
No. 77 Yandunshan Road SE DECISION MADE: 18-MAR-21
Dagang Zhenjiang CN 212132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyHomeDoc
MyHomeDoc Ltd. 510(k) NO: K202483(Traditional)
ATTN: Orly Maor PHONE NO : 972 76 8899800
13 Zarchin St. SE DECISION MADE: 23-MAR-21
Ra'anana IL 4366241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-IO Intraosseous Vascular Access System
Teleflex Medical 510(k) NO: K202492(Traditional)
ATTN: Rachel Rehl PHONE NO : 919 4332588
3015 Carrington Mill Blvd. SE DECISION MADE: 22-MAR-21
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promaxo MRI System
Promaxo, Inc. 510(k) NO: K202518(Traditional)
ATTN: Eva Hellman PHONE NO : 510 7706961
70 Washington St, Suite 407 SE DECISION MADE: 03-MAR-21
Oakland CA 94607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgivisio system
Surgivisio 510(k) NO: K202547(Traditional)
ATTN: Vincent Lere PHONE NO : 33 4 58005721
Zone Mayencin II, Parc Equation - SE DECISION MADE: 26-MAR-21
Gières FR 38610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Wanxinda (Guangzhou) Technology Pr510(k) NO: K202548(Traditional)
ATTN: Zeng Xueping PHONE NO : 0086 020 61816666
Ling Xi Road, Accessory Section 2,SE DECISION MADE: 10-MAR-21
Guangzhou CN 510800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
Stryker Sustainability Solutions 510(k) NO: K202554(Traditional)
ATTN: Aphrodeja Crutch PHONE NO : 404 9931981
1810 W. Drake Dr. SE DECISION MADE: 16-MAR-21
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Body Infrared Thermometer HT-820D
Dongguan Xintai Instrument Co., Lt510(k) NO: K202591(Traditional)
ATTN: Wei Wang PHONE NO : 86 769 82612006
South of Shuangyong Road, ChengyanSE DECISION MADE: 09-MAR-21
Dongguan CN 523710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask
Qinghai Zhong Dao Win-win Medical 510(k) NO: K202628(Traditional)
ATTN: Zhaochu Chen PHONE NO : 086 133 81230018
No.36 Jingsan Road, Biological ParSE DECISION MADE: 19-MAR-21
Xining CN 810000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical disposable face mask non sterile
Guangdong Zhong Ling Industrial Gr510(k) NO: K202650(Traditional)
ATTN: Ann Ho PHONE NO : 86 769 22175828
Room 101, Building 1, No. 5, ShengSE DECISION MADE: 24-MAR-21
Xinhe Wanjiang, Dongguan CN 52304510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid E80/ Vivid E90/ Vivid E95
GE Medical Systems Ultrasound and 510(k) NO: K202658(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 05-MAR-21
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI Surgical System
Sight Sciences, Inc. 510(k) NO: K202678(Traditional)
ATTN: Edward J. Sinclair PHONE NO : 650 2189149
440 Campbell Ave, Suite 100 SE DECISION MADE: 01-MAR-21
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoWave Pain Relief and Recovery System, Model# T16-2020
Eva Medtec, Inc 510(k) NO: K202693(Traditional)
ATTN: Irene Waldridge PHONE NO : 612 2513949
6300 W. Old Shakopee Road, Suite 1SE DECISION MADE: 05-MAR-21
Bloomington MN 55438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Masks
Intco Medical(HK) Co., Ltd. 510(k) NO: K202708(Third Party - Traditional)
ATTN: Max Li PHONE NO : 86 511 83174088
Flat/RM 19c, Lockhart Centre 301-3SE DECISION MADE: 30-MAR-21
Hong Kong CN 999077 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Disposable Medical Face Mask
Wanxinda (Guangzhou) Technology Pr510(k) NO: K202710(Traditional)
ATTN: Zeng Xueping PHONE NO : 0086 020 61816666
Ling Xi Road, Accessory Section 2,SE DECISION MADE: 09-MAR-21
Guangzhou CN 510800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETD4000
TheraSigma, LLC 510(k) NO: K202725(Traditional)
ATTN: Jim Klett PHONE NO : 949 6899892
4060 South Grant St. Suite 102 SE DECISION MADE: 26-MAR-21
Washougal WA 98671 510(k) STATEMENT
DEVICE: Med-Link Temp-pulse Oximeter
Shenzhen Med-link Electronics Tech510(k) NO: K202743(Traditional)
ATTN: Jialing Zhang PHONE NO : 0086 755 61568825 884
4th snf 5th Floor, Building Two, HSE DECISION MADE: 01-MAR-21
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TandemHeart Pump and Escort Controller
CardiacAssist, Inc. 510(k) NO: K202751(Traditional)
ATTN: Megan Walsh PHONE NO : 412 2307324
620 Alpha Drive, Suite 2 SE DECISION MADE: 26-MAR-21
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iHealth Wireless No-Touch Forehead Thermometer
Andon Health Co., Ltd. 510(k) NO: K202753(Traditional)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 08-MAR-21
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s-Clean SQ-SL Implant System Mini
Dentis Co., Ltd. 510(k) NO: K202773(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 18-MAR-21
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip pulse oximeter
Shenzhen LEPU Intelligent Medical 510(k) NO: K202776(Traditional)
ATTN: Aaron Lin PHONE NO : 86 755 86952278
North side of floor 3, BLD 9 BaiWaSE DECISION MADE: 01-MAR-21
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPHECY Preoperative Navigation Alignment System
Wright Medical Technology, Inc. 510(k) NO: K202815(Traditional)
ATTN: Paxia Her PHONE NO : 952 6837443
10801 Nesbitt Ave S SE DECISION MADE: 10-MAR-21
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRS Procedure Face Mask
Blackbriar Regulatory Services, LL510(k) NO: K202824(Abbreviated)
ATTN: Vincent Angelico PHONE NO : 954 6040972
820 Southlake Boulevard SE DECISION MADE: 25-MAR-21
Richmond VA 23236 510(k) STATEMENT
DEVICE: Andorate Universal Endoscope Tip Guard
GA Health Company Limited 510(k) NO: K202838(Traditional)
ATTN: Cindy Ye PHONE NO : 852 28 339010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 05-MAR-21
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOGas 4 Endo-SteriTest RRBI
Andersen Sterilizers, Inc. 510(k) NO: K202879(Traditional)
ATTN: William K. Andersen PHONE NO : 336 3768622
3154 Caroline Drive SE DECISION MADE: 03-MAR-21
Haw River NC 27258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Able Medical Devices Valkyrie Thoracic Fixation System
JM Longyear Manufacturing, LLC D.B510(k) NO: K202889(Traditional)
ATTN: Wade DePas PHONE NO : 906 3723213
512 4th Street SE DECISION MADE: 02-MAR-21
Gwinn MI 49841 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Monitor
Guangdong Transtek Medical Electro510(k) NO: K202891(Traditional)
ATTN: Endless Chan PHONE NO : 86 188 14069928
Zone B, No.105, Dongli Road, TorchSE DECISION MADE: 09-MAR-21
Zhongshan CN 528437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Face Mask
Jiangsu Excellence Medical Supplie510(k) NO: K202905(Traditional)
ATTN: Jing Zhu PHONE NO : 86 519 83635058
No.65 Huiling West Road, Zouqu TowSE DECISION MADE: 26-MAR-21
Changzhou CN 203144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroCap (Model DEC22)
Memory MD Inc 510(k) NO: K202913(Traditional)
ATTN: Boris Goldstein PHONE NO : 1 215 3416373
125 Wilbur Place, Suite 170 SE DECISION MADE: 05-MAR-21
Bohemia NY 111716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LigaSure Exact Dissector, Nano-coated
Covidien llc 510(k) NO: K202917(Traditional)
ATTN: Nancy Sauer PHONE NO : 720 3615290
5920 Longbow Drive SE DECISION MADE: 23-MAR-21
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
Ceragem Co, Ltd. 510(k) NO: K202937(Traditional)
ATTN: Hyeonggeun Hwang PHONE NO :
10, Jeongja 1-gil, Seonggeo-eup, SSE DECISION MADE: 18-MAR-21
Cheonan-si KR 31041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEBULAE SRS Laparoscopic Surgical Smoke Removal System
Northgate Technologies Inc. 510(k) NO: K202944(Traditional)
ATTN: Todd Gatto PHONE NO : 224 8562250
1591 Scottsdale Court SE DECISION MADE: 25-MAR-21
Elgin IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AquaBeam Robotic System
PROCEPT BioRobotics Corporation 510(k) NO: K202961(Traditional)
ATTN: Sara Muddell PHONE NO : 650 2327217
900 Island Drive, Suite 101 SE DECISION MADE: 11-MAR-21
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightWalker Laser System Family
Fotona d.o.o. 510(k) NO: K202985(Traditional)
ATTN: Pucer Anja PHONE NO : 386 1 5009274
Stegne 7 SE DECISION MADE: 19-MAR-21
Ljubljana SI SI-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Toro-L Interbody Fusion System
Integrity Implants Inc 510(k) NO: K203038(Traditional)
ATTN: Lauren Kamer PHONE NO : 561 5293861
354 Hiatt Drive SE DECISION MADE: 26-MAR-21
Palm Beach Gardens FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Movement and Compressions System (the MAC System)
Recovery Force, LLC 510(k) NO: K203052(Traditional)
ATTN: Jeff Schwegman PHONE NO : 317 6054696
10022 Lantern Rd., Suite 100 SE DECISION MADE: 21-MAR-21
Fishers IN 46037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexSys
GME German Medical Engineering Gmb510(k) NO: K203054(Traditional)
ATTN: Stefan Schulze PHONE NO : 49 9131 93415910
Dreikoenigstrasse 6-8 SE DECISION MADE: 05-MAR-21
Erlangen DE 91054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
Johnson & Johnson Surgical Vision,510(k) NO: K203060(Traditional)
ATTN: Amanda Houston PHONE NO : 512 7898317
1700 East St. Andrew Place SE DECISION MADE: 12-MAR-21
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICU Health Surgical Mask
Plastikon Industries 510(k) NO: K203064(Abbreviated)
ATTN: Paul Gutwald PHONE NO : 510 4001010
688 Sandoval Way SE DECISION MADE: 23-MAR-21
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumbar Spine Truss System Plating Solution (LSTS-PS)
4Web, Inc. 510(k) NO: K203065(Traditional)
ATTN: Jessee Hunt PHONE NO : 800 2857090
2801 Network Blvd., Suite 620 SE DECISION MADE: 10-MAR-21
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magic 360 Power Wheelchair
Magic Mobility 510(k) NO: K203083(Traditional)
ATTN: Alex Suen PHONE NO : 61 3 87915600
3 International Court SE DECISION MADE: 17-MAR-21
Scoreby AU 3179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-PLO2R
Belluscura LLC 510(k) NO: K203086(Traditional)
ATTN: Sarah Clark PHONE NO : 214 3968313
5504 Democracy Dr, Suite 200 SE DECISION MADE: 02-MAR-21
Plano TX 75024 510(k) STATEMENT
DEVICE: Secure Wear USA Surgical Face Mask
Secured Ortho Manufacturing of Ame510(k) NO: K203101(Abbreviated)
ATTN: Vincent Benenati PHONE NO : 516 3433372
28 West Jefryn Boulevard Suite C SE DECISION MADE: 31-MAR-21
Deer Park NY 11729 510(k) STATEMENT
DEVICE: SensorX
Durr Dental SE 510(k) NO: K203116(Traditional)
ATTN: Oliver Lange PHONE NO : 490 7142 705190
Hopfigheimer Str. 17 SE DECISION MADE: 19-MAR-21
Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
ENvizion Medical Ltd. 510(k) NO: K203133(Traditional)
ATTN: Doron Besser PHONE NO : 972 72 2288240
7 Haarad St. SE DECISION MADE: 24-MAR-21
Tel Aviv IL 6971060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Akesis Galaxy RTi
Akesis Inc 510(k) NO: K203146(Traditional)
ATTN: Christopher Brown PHONE NO : 925 4081381
5129 Commercial Circle SE DECISION MADE: 05-MAR-21
Concord CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNATAPE Suture
Medos International SARL 510(k) NO: K203186(Traditional)
ATTN: Tatyana Korsunsky PHONE NO : 508 8283122
Chemin-Blanc 38, Case Postale SE DECISION MADE: 18-MAR-21
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADD
H&abyz Co., Ltd. 510(k) NO: K203188(Traditional)
ATTN: Namkyu Hur PHONE NO : 82 070 46589300
1F, 2-Dong, 41-16 Cheoinseong-Ro, SE DECISION MADE: 12-MAR-21
Yongin-Si KR 17118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Intraosseous Infusion System
Bard Access Systems, Inc(BAS)[Whol510(k) NO: K203193(Traditional)
ATTN: Connor Dahl PHONE NO : 801 5225834
605 North 5600 West SE DECISION MADE: 04-MAR-21
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigated Spine Instruments
Stryker Spine 510(k) NO: K203205(Traditional)
ATTN: Megan Callanan PHONE NO : 551 2422429
600 Hope Parkway SE SE DECISION MADE: 23-MAR-21
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
Canon Medical Systems Corporation 510(k) NO: K203225(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 24-MAR-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VBrain
Vysioneer Inc. 510(k) NO: K203235(Traditional)
ATTN: Jeni-Tang Lu PHONE NO : 609 8658659
33 Rogers. St., # 308 SE DECISION MADE: 19-MAR-21
Cambridge MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TaiChiC
Our United Corporation 510(k) NO: K203250(Traditional)
ATTN: Qi Liu PHONE NO : 86 15 389012257
Room 10301, 3rd Floor, Unit 1, BloSE DECISION MADE: 12-MAR-21
Xi'an CN 710018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-unit Abutments for CONELOG
BioHorizons Implant Systems, Inc. 510(k) NO: K203252(Traditional)
ATTN: Bill Hornbuckle PHONE NO : 205 9677887
2300 Riverchase Center SE DECISION MADE: 16-MAR-21
Birmingham AL 35244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucent 3D Spinal System
Spinal Elements, Inc. 510(k) NO: K203254(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 26-MAR-21
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Imbio RV/LV Software
Imbio, LLC 510(k) NO: K203256(Traditional)
ATTN: William McLain PHONE NO : 717 6569656
1015 Glenwood Avenue, Floor 4 SE DECISION MADE: 09-MAR-21
Minneapolis MN 55405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Lung CAD
Siemens Healthcare GmbH 510(k) NO: K203258(Traditional)
ATTN: Abhineet Johri PHONE NO : 49 9191 184429
Siemensstr. 1 SE DECISION MADE: 31-MAR-21
Forchheim DE 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FairFix Adjustable Button System
Medacta International SA 510(k) NO: K203259(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 26-MAR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Inquiry Steerable Diagnostic EP Catheter
Innovative Health, LLC. 510(k) NO: K203261(Special)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road Suite 100 SE DECISION MADE: 05-MAR-21
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
Echosens 510(k) NO: K203273(Traditional)
ATTN: Karine Bonenfant PHONE NO : 33 144 827856
6 rue Ferrus SE DECISION MADE: 25-MAR-21
Paris FR 75014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Recon Support Catheter
C.R. Bard, Inc. 510(k) NO: K203275(Third Party - Traditional)
ATTN: Andrew Quach PHONE NO : 480 5978252
1625 West 3rd St SE DECISION MADE: 01-MAR-21
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
Gold Standard Diagnostics 510(k) NO: K203289(Traditional)
ATTN: Napoleon Monce PHONE NO : 530 7598000
2851 Spafford St. SE DECISION MADE: 22-MAR-21
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Gold Standard Diagnostics 510(k) NO: K203292(Traditional)
ATTN: Napoleon Monce PHONE NO : 530 7598000
2851 Spafford St. SE DECISION MADE: 22-MAR-21
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Gold Standard Diagnostics 510(k) NO: K203295(Traditional)
ATTN: Napoleon Monce PHONE NO : 530 7598000
2851 Spafford St. SE DECISION MADE: 22-MAR-21
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Gold Standard Diagnostics 510(k) NO: K203296(Traditional)
ATTN: Napoleon Monce PHONE NO : 530 7598000
2851 Spafford St. SE DECISION MADE: 22-MAR-21
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K203323(Traditional)
ATTN: Janine F. Reyes PHONE NO : 714 6697853
1385 Shimoshigami SE DECISION MADE: 04-MAR-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTRUX Mini Ti Spacer System
Orthofix Inc. 510(k) NO: K203342(Traditional)
ATTN: Natalia Volosen PHONE NO : 214 9372145
3451 Plano Parkway SE DECISION MADE: 18-MAR-21
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OEC 3D
GE OEC Medical Systems, Inc. 510(k) NO: K203346(Traditional)
ATTN: Kenny M. Bello PHONE NO : 801 2013986
384 N Wright Brothers Drive SE DECISION MADE: 05-MAR-21
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perfit ZR HT Dental Zirconia blank
Vatech acucera, Inc. 510(k) NO: K203351(Traditional)
ATTN: Kyung Wook Kwon PHONE NO : 82 31 80051851
2544, Nambuk-daero, Idong-eup, CheSE DECISION MADE: 08-MAR-21
Yongin-si KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solitaire X Revascularization Device
Micro Therapeutics, Inc d/b/a ev3 510(k) NO: K203358(Traditional)
ATTN: Kevin Kong PHONE NO : 408 4620073
9775 Toledo Way SE DECISION MADE: 01-MAR-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProLift Wedge Expandable Spacer System
Life Spine, Inc. 510(k) NO: K203361(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 17-MAR-21
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulsehaler
Respinova Ltd. 510(k) NO: K203378(Traditional)
ATTN: Cliff Ansel PHONE NO : 972 58 6878812
Hachoshlim 8 SE DECISION MADE: 31-MAR-21
Herzliya IL 4672408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System-Easy Pack
JJGC Industria e Comercio de Mater510(k) NO: K203382(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 15-MAR-21
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlignRT Plus
Vision RT Ltd 510(k) NO: K203387(Traditional)
ATTN: Jade Dunphy PHONE NO : 44 208 3464300
Dove House, Arcadia Avenue SE DECISION MADE: 04-MAR-21
London GB N3 2JU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K203391(Traditional)
ATTN: Ma Chao PHONE NO : 86 755 81886573
Keji 12th Road South, Hi-Tech InduSE DECISION MADE: 23-MAR-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PleuraFlow System with FlowGlide
ClearFlow, Inc, 510(k) NO: K203394(Special)
ATTN: Serrah Namini PHONE NO : 714 9165014
140 Technology Drive Suite 100 SE DECISION MADE: 02-MAR-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DVT-4000S
Daesung Maref CO., LTD. 510(k) NO: K203417(Traditional)
ATTN: Su Hyeon So PHONE NO : 82 31 4597211
298-24, Gongdan-Ro SE DECISION MADE: 28-MAR-21
Gunpo-Si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
BDC Dental Corporation Ltd. 510(k) NO: K203425(Third Party - Traditional)
ATTN: Lifang Zhang PHONE NO : 86 20 32052929
Part 3, No.1 Guanchong Section, ShSE DECISION MADE: 05-MAR-21
Guangzhou CN 511450 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Ziehm Vision RFD
Ziehm Imaging GmbH 510(k) NO: K203428(Special)
ATTN: Stefan Fiedler PHONE NO : 49 0911 2172219
Lina-Ammon-Strasse 10 SE DECISION MADE: 17-MAR-21
Nuremberg DE 90471 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
Siemens Medical Solutions USA, Inc510(k) NO: K203443(Traditional)
ATTN: Andrew Turner PHONE NO : 610 8505627
40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 31-MAR-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEE HA Cage
NGMedical GmbH 510(k) NO: K203444(Traditional)
ATTN: Stella Hahn PHONE NO : 49 6873 99997100
Talsperrenblick 5 SE DECISION MADE: 18-MAR-21
Nonnweiler DE 66620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORO QR3 Headrest System (Aluminum)
pro med instruments GmbH 510(k) NO: K203505(Traditional)
ATTN: Muhammad Zubair PHONE NO : 49 0761 38422210
Boetziger Str. 38 SE DECISION MADE: 29-MAR-21
Freiburg DE 79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quicktome
Omniscient Neurotechnology Pty Ltd510(k) NO: K203518(Traditional)
ATTN: Arie Henkin PHONE NO : 1 416 5009985
Level 10, 580 George Street SE DECISION MADE: 09-MAR-21
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FineCross M3
Ashitaka Factory of Terumo Corpora510(k) NO: K203521(Traditional)
ATTN: Vaibhav Sivaramakrishan PHONE NO : 609 6133958
150 Maimaigi-cho SE DECISION MADE: 03-MAR-21
Fujinomiya JP 418-0015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nalu Neurostimulation System
Nalu Medical, Inc. 510(k) NO: K203547(Traditional)
ATTN: Pauline Lieu PHONE NO : 858 4426370
2320 Faraday Ave. Suite 100 SE DECISION MADE: 25-MAR-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIZONE VP4 Test Pack
TSO3 Inc., Now a part of Stryker 510(k) NO: K203560(Traditional)
ATTN: Karan Modi PHONE NO : 269 8880305
2505, avenue Dalton SE DECISION MADE: 24-MAR-21
Québec CA G1P 3S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
Hivox Biotek Inc. 510(k) NO: K203574(Traditional)
ATTN: Ruby Lu PHONE NO : 886 2 25112668 510
SF, No. 123, Xingde Road, SanchongSE DECISION MADE: 10-MAR-21
New Taipei City TW 241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORZA Ti Spacer System
Orthofix Inc. 510(k) NO: K203576(Traditional)
ATTN: Natalia Volosen PHONE NO : 214 9372145
3451 Plano Parkway SE DECISION MADE: 03-MAR-21
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tigertriever and Tigertriever 17 Revascularization Devce
Rapid Medical Ltd. 510(k) NO: K203592(Traditional)
ATTN: Orit Yaniv PHONE NO : 972 72 2503331
Carmel Building, POB 337 SE DECISION MADE: 23-MAR-21
Yokneam IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Examination Gloves
Guang Dong Kingfa SCI. & TECH.CO.,510(k) NO: K203593(Traditional)
ATTN: Xiaoge Yu PHONE NO : 86 135 70952157
No. 28 Delong Ave., Shijiao Town, SE DECISION MADE: 19-MAR-21
Qingyuan CN 511545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaWrap
Alafair Biosciences Inc 510(k) NO: K203600(Traditional)
ATTN: Angela Mallery PHONE NO : 800 2065586
6101 W Courtyard Drive ste 2-225 SE DECISION MADE: 09-MAR-21
Austin TX 78730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
Meris Investment Group 510(k) NO: K203606(Traditional)
ATTN: Gary Maas PHONE NO : 651 4025577
16688 7th Street South SE DECISION MADE: 10-MAR-21
Lakeland MN 55043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capture-CMV
Immucor, Inc. 510(k) NO: K203612(Traditional)
ATTN: Steven Appel PHONE NO : 770 4412051
3130 Gateway Drive SE DECISION MADE: 22-MAR-21
Norcross GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monarch Bronchoscope
Auris Health Inc., a Johnson and J510(k) NO: K203614(Traditional)
ATTN: Somi Ekwealor PHONE NO : 408 3205385
150 Shoreline Drive SE DECISION MADE: 11-MAR-21
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxFOV 2
GE Medical Systems, LLC. 510(k) NO: K203617(Traditional)
ATTN: Amy Yang PHONE NO : 414 5143904
3000 N Grandview Blvd SE DECISION MADE: 02-MAR-21
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent EasyGuide Kit Cases
JJGC Industria e Comercio de Mater510(k) NO: K203618(Traditional)
ATTN: Camila da Silva Esteves PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 09-MAR-21
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aneroid Sphygmomanometer
Wuxi Exanovo Medical Instrument Co510(k) NO: K203620(Traditional)
ATTN: Xiao Huang PHONE NO : 86 0510 83791431
No. 42, Xixin Road, Zhangjing, XibSE DECISION MADE: 23-MAR-21
Wuxi CN 214194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Denture Pro
EnvisionTEC GmbH 510(k) NO: K203641(Traditional)
ATTN: Ruediger van Bernum PHONE NO : 49 2043 987545
Brusseler Straße 51 SE DECISION MADE: 30-MAR-21
Gladbeck DE D-45968 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI PPG Patient Cable
Ivy Biomedical Systems, Inc. 510(k) NO: K203653(Traditional)
ATTN: Alejandra Aceves PHONE NO : 203 4814183
11 Business Park Drive SE DECISION MADE: 02-MAR-21
Branford CT 06405 510(k) STATEMENT
DEVICE: Vinyl Examination Gloves(Yellow)
Lutai Medical Technology Co.,LTD. 510(k) NO: K203666(Traditional)
ATTN: Xiaomeng Xiaomeng Li PHONE NO : 86 186 53343268
Tiandingfeng Road SE DECISION MADE: 12-MAR-21
Dezhou CN 251500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Registration
Brainlab AG 510(k) NO: K203679(Special)
ATTN: Chiara Cunico PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 18-MAR-21
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neurosign V4 Intraoperative Nerve Monitor
Magstim Company Ltd. 510(k) NO: K203684(Traditional)
ATTN: Rosie Hunt PHONE NO : 440 1994 240798
Spring Gardens SE DECISION MADE: 17-MAR-21
Whitland GB SA34 0HR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Xiantao Zhongyi Safety & Protectio510(k) NO: K203685(Traditional)
ATTN: Yang Xi PHONE NO : 86 136 51733375
No.101, Xianyuan Road SE DECISION MADE: 26-MAR-21
Xiantao CN 433000 510(k) STATEMENT
DEVICE: BC Reflex Uni Knee System
Bodycad Laboratories, Inc. 510(k) NO: K203697(Special)
ATTN: Nadine Adia PHONE NO : 418 5271388
SE DECISION MADE: 12-MAR-21
Quebec City CA G1N 4R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-Q View
First Source, Inc. 510(k) NO: K203703(Traditional)
ATTN: Susan Ryan-Kron PHONE NO : 585 2721690
3495 Winton Place, Bldg E Ste 1 SE DECISION MADE: 24-MAR-21
Rochester NY 14623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
ShenZhen ZhengKang Technology Co.,510(k) NO: K203707(Traditional)
ATTN: Huayong Yang PHONE NO : 86 0755 83260864
2&3/F, Building A, No.3 FuXing Yi SE DECISION MADE: 12-MAR-21
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spark Clear Aligner System
Ormco Corporation 510(k) NO: K203737(Traditional)
ATTN: Frank Ray PHONE NO : 704 5877227
200 S Kraemer Blvd SE DECISION MADE: 22-MAR-21
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shoulder System - TiNbN Coating
Medacta International SA 510(k) NO: K203755(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 02-MAR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Imperative Care Inc. 510(k) NO: K203764(Traditional)
ATTN: Kristin Ellis PHONE NO : 408 8570934
1359 Dell Avenue SE DECISION MADE: 03-MAR-21
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIC disposable medical mask
The Aleen International Corporatio510(k) NO: K203775(Traditional)
ATTN: Can Huang PHONE NO : 086 62 3496999
Jiutian Green Science and TechnoloSE DECISION MADE: 12-MAR-21
Heyuan CN 517000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Masks, Model SNN200640 & MN112
SQ Medical Supplies Inc. 510(k) NO: K203776(Traditional)
ATTN: Jonathan Lim PHONE NO : 888 9128168
8889 West Olympic Blvd. Suite 1000SE DECISION MADE: 25-MAR-21
Beverly Hills CA 90211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harvester SI: Sacroiliac Fixation System
Spinus International, Inc. 510(k) NO: K203780(Traditional)
ATTN: Ron Oman PHONE NO : 254 7604173
7200 North Interstate Highway 35, SE DECISION MADE: 23-MAR-21
Georgetown TX 79626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DermaV Laser System
Lutronic Corporation 510(k) NO: K203788(Traditional)
ATTN: Jhung Won Vojir PHONE NO : 888 5887644
Lutronic Center, 219, Sowon-Ro SE DECISION MADE: 26-MAR-21
Deogyang-Gu, Goyang-si KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ponto Bone Anchored Hearing System, MONO Surgery Kit
Oticon Medical AB 510(k) NO: K203807(Special)
ATTN: Carolina Anker Wessling PHONE NO : 46 76 1686332
Datavagen 37B SE DECISION MADE: 03-MAR-21
Askim SE SE-436 32 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProFound AI Software V3.0
iCAD Inc. 510(k) NO: K203822(Special)
ATTN: Heather Reed PHONE NO : 603 3091945
98 Spit Brook Rd. Suite 100 SE DECISION MADE: 12-MAR-21
Nashua NH 03062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LaserCap Family of Lasers 300, 224, 120 & 80
Transdermal Cap, Inc. 510(k) NO: K203826(Traditional)
ATTN: Michael Rabin PHONE NO : 440 2411846
26 Alpha Park SE DECISION MADE: 29-MAR-21
Highland Heights OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMI
Epitel, Inc. 510(k) NO: K203827(Traditional)
ATTN: Mark Lehmkuhle PHONE NO : 801 4976297
124 S. 400 E. SE DECISION MADE: 29-MAR-21
Salt Lake City UT 84111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Patella SuturePlates
Arthrex Inc. 510(k) NO: K203834(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 25-MAR-21
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOMEDENT Apex locator, WISMY Apex locator
ChangZhou BoMedent Medical Technol510(k) NO: K203836(Traditional)
ATTN: Zhang Lili PHONE NO : 86 0519 88991980
No.9 Changyang Road, West Taihu ScSE DECISION MADE: 30-MAR-21
Changzhou CN 213100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MI DeTACH
Biorep Technologies, Inc 510(k) NO: K210006(Traditional)
ATTN: Victoria Enjamio PHONE NO : 305 3304449 403
15804 NW 57th Avenue SE DECISION MADE: 04-MAR-21
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK Revision & Hinge Extension - TiNbN Coating
Medacta International SA 510(k) NO: K210010(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 02-MAR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
Unimed Medical Supplies, Inc. 510(k) NO: K210019(Traditional)
ATTN: Linbin Ye PHONE NO : 86 755 26695137
Bld#8, Nangang 3rd Industrial ParSE DECISION MADE: 04-MAR-21
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HySil Plus Impression Materials
Osstem Implant Co., Ltd. 510(k) NO: K210041(Traditional)
ATTN: Jinwoo Bae PHONE NO : 82 51 8502500
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 18-MAR-21
Busan KR 48002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ Distal Lateral Femur Plate 4.5 System
AAP Implantate AG 510(k) NO: K210043(Traditional)
ATTN: Agnieszka Mierzejewska PHONE NO : 11 49 3075019129
Lorenzweg 5 SE DECISION MADE: 03-MAR-21
Berlin DE 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Exam Glove, Powder Free
Real Star Medical Technology Co., 510(k) NO: K210057(Traditional)
ATTN: Nie Jian PHONE NO : 86 139 53305660
Youdi Industry Park in Dongying DiSE DECISION MADE: 31-MAR-21
Dongying CN 257100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Exam Glove, Powder Free
Great Harvest Trading Co., Ltd. 510(k) NO: K210058(Traditional)
ATTN: Chongfeng Zhao PHONE NO : 86 13 508943885
Xinghe Road SE DECISION MADE: 30-MAR-21
Dongying CN 257100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink Mfx Implant System
In2Bones USA, LLC 510(k) NO: K210060(Traditional)
ATTN: Christine Scifert PHONE NO : 901 8318053
6000 Poplar Ave, Suite 115 SE DECISION MADE: 12-MAR-21
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS System (Version 5.1.0)
Surgical Information Sciences, Inc510(k) NO: K210071(Traditional)
ATTN: Ann Quinlan-Smith PHONE NO : 612 3250187
10405 6th Avenue N, Suite 110 SE DECISION MADE: 31-MAR-21
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker ProCinch Adjustable Loop Device
Stryker Endoscopy 510(k) NO: K210078(Traditional)
ATTN: Victoria Milich PHONE NO : 508 6426132
5900 Optical Court SE DECISION MADE: 11-MAR-21
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guidion
IMDS Operations B.V. 510(k) NO: K210110(Traditional)
ATTN: Edwin Schulting PHONE NO : 31 508 200230
Ceintuurbaan Noord 150 SE DECISION MADE: 31-MAR-21
Roden NL 9301 NZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BonOs HV, BonOs MV, BonOs LV
Osartis GmbH 510(k) NO: K210120(Traditional)
ATTN: Volker Stirnal PHONE NO : 49 6071 9290
Auf der Beune 101 SE DECISION MADE: 19-MAR-21
Munster DE 64839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
OSARTIS GmbH 510(k) NO: K210125(Traditional)
ATTN: Volker Stirnal PHONE NO : 49 6071 9290
Auf der Beune 101 SE DECISION MADE: 19-MAR-21
Munster DE 64839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fiber Dust
Quanta System Spa 510(k) NO: K210142(Traditional)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
via Acquedotto 109 SE DECISION MADE: 11-MAR-21
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Elan 1.5T, MRT-2020, V6.0
Canon Medical Systems Corporation 510(k) NO: K210164(Traditional)
ATTN: Janine F. Reyes PHONE NO : 714 6697853
1385 Shimoshigami SE DECISION MADE: 10-MAR-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StarGuide
GE Healthcare 510(k) NO: K210173(Traditional)
ATTN: George Mashour PHONE NO : 972 4 8563666 639
4 Hayozma Street SE DECISION MADE: 29-MAR-21
Tirat Hacarmel IL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nordiwell Surgical Face Mask
Changzhou Combat Protective Equipm510(k) NO: K210181(Special)
ATTN: Yanmei Song PHONE NO : 86 519 85190068
QingSiTang village, Henglin Town, SE DECISION MADE: 09-MAR-21
Changzhou CN 213101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DB-Composite
Dimensional Bioceramics, LLC 510(k) NO: K210193(Traditional)
ATTN: Duran N. Yetkinliner PHONE NO : 408 7576603
2161 Delaware Ave, Suite A SE DECISION MADE: 15-MAR-21
Santa Cruz CA 95060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Synthes (USA) products, LLC 510(k) NO: K210205(Traditional)
ATTN: Satapa Dhamankar PHONE NO : 1 610 7196574
1301 Goshen Parkway SE DECISION MADE: 26-MAR-21
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Humeral Eccentric Reverse Metaphysis
Medacta International SA 510(k) NO: K210207(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 26-MAR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viz ICH
Viz.ai, Inc. 510(k) NO: K210209(Traditional)
ATTN: Gregory Ramina PHONE NO : 239 8983105
350 Rhode Island St, Suite 240 SE DECISION MADE: 23-MAR-21
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Feng Chun Yuan Medical Equipment (510(k) NO: K210225(Third Party - Traditional)
ATTN: Qiyuan Ning PHONE NO : 86 755 27900876
Room 1304, Technology Innovation PSE DECISION MADE: 04-MAR-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PicoSure Workstation
Cynosure LLC 510(k) NO: K210226(Traditional)
ATTN: Michael King PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 30-MAR-21
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph Vision Quadra PET/CT System
Siemens Medical Solutions USA, Inc510(k) NO: K210262(Special)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 03-MAR-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OverStitch Sx Endoscopic Suturing System
Apollo Endosurgery Inc. 510(k) NO: K210266(Special)
ATTN: David Hooper PHONE NO : 512 8523757
1120 South Capital of Texas Hwy., SE DECISION MADE: 02-MAR-21
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Modulus ALIF System
NuVasive, Incorporated 510(k) NO: K210271(Special)
ATTN: Jessica LeBlanc PHONE NO : 951 816 0973
7475 Lusk Blvd. SE DECISION MADE: 01-MAR-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Rapid Readout Biological Indicator, 1295
3M Company 510(k) NO: K210277(Special)
ATTN: Mary Fretland PHONE NO : 651 7372296
3M Center, Building 275-5W-06 SE DECISION MADE: 03-MAR-21
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Geistlich Mucograft®, Geistlich Mucograft® Seal
Geistlich Pharma AG 510(k) NO: K210280(Special)
ATTN: Marco Steiner PHONE NO : 41 41 4926764
Bahnhofstrasse 40 SE DECISION MADE: 03-MAR-21
Wolhusen CH CH-6110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRION Embolic Protection System
Cardiovascular Systems Inc. 510(k) NO: K210282(Special)
ATTN: Erika Huffman PHONE NO : 877 2740360
1225 Old Hwy 8 NW SE DECISION MADE: 03-MAR-21
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adaptable Ortho Innovations Intramedullary Nail System
Adaptable Ortho Innovations, LLC 510(k) NO: K210285(Traditional)
ATTN: Steve Palin PHONE NO : 315 4392343
65 Main Street SE DECISION MADE: 18-MAR-21
Potsdam NY 13676 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cure 2.0 Anterior Cervical Plate (ACP) System
Meditech Spine, LLC 510(k) NO: K210286(Special)
ATTN: Bruce Dunaway PHONE NO : 678 974 5287
1447 Peachtree St NE Suite 440 SE DECISION MADE: 18-MAR-21
Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriClip LAA Exclusion System
AtriCure, Inc. 510(k) NO: K210293(Special)
ATTN: Mary Galeano PHONE NO : 513 2576279
7555 Innovation Way SE DECISION MADE: 03-MAR-21
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cios Select (VA21) Image Intensifier
Siemens Medical Solutions USA, Inc510(k) NO: K210307(Special)
ATTN: Cordell Fields PHONE NO : 610 3063167
40 Liberty Boulevard 65-1A SE DECISION MADE: 04-MAR-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPOWR Porous Femur with HAnano SurfaceTM
Encore Medical, L.P. 510(k) NO: K210308(Traditional)
ATTN: Christine Chesnutt PHONE NO : 512 8346207
9800 Metric Blvd. SE DECISION MADE: 30-MAR-21
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cios Select (VA21) Flat Panel
Siemens Medical Solutions USA, Inc510(k) NO: K210309(Special)
ATTN: Cordell Fields PHONE NO : 610 3063167
40 Liberty Boulevard 65-1A SE DECISION MADE: 05-MAR-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mars1717X Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd. 510(k) NO: K210314(Special)
ATTN: Meng Li PHONE NO : 86 0512 53690872
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 02-MAR-21
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mars 1417X Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd. 510(k) NO: K210316(Special)
ATTN: Meng Li PHONE NO : 86 0512 53690872
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 03-MAR-21
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
CareFusion 2200 Inc 510(k) NO: K210324(Special)
ATTN: Jane Weber PHONE NO : 847 3628094
75 North Fairway Drive SE DECISION MADE: 04-MAR-21
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOLLO Anterior Cervical Plate (ACP) System
Aurora Spine, Inc. 510(k) NO: K210325(Traditional)
ATTN: Laszlo Garamszegi PHONE NO : 760 4242004
1930 Palomar Point Way, Suite 103 SE DECISION MADE: 23-MAR-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeSept Blunt Needle
Pressure Products Medical Device M510(k) NO: K210328(Special)
ATTN: Andrew Amour PHONE NO : 610 5432324
1 School Street SE DECISION MADE: 05-MAR-21
Morton PA 19070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiaPaste
Diadent Group International 510(k) NO: K210333(Special)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 25-MAR-21
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hexanium TLIF
SpineVision SAS 510(k) NO: K210359(Special)
ATTN: Arnaud Brisard PHONE NO : 33 153 332552
10 rue de la Renaissance SE DECISION MADE: 10-MAR-21
Batiment E FR 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apex 3D Total Ankle Replacement System
Paragon 28, Inc. 510(k) NO: K210390(Special)
ATTN: Haylie Hertz PHONE NO : 888 7281888
14445 Grasslands Dr. SE DECISION MADE: 06-MAR-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WorkMate Claris System
Abbott 510(k) NO: K210392(Special)
ATTN: Ed Sandberg PHONE NO : 651 2458398
One St. Jude Medical Drive SE DECISION MADE: 11-MAR-21
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity™ OCT System, PASS OCT® Spinal System
Medtronic 510(k) NO: K210449(Special)
ATTN: Shweta Sharma PHONE NO : 901 3992425
1800 Pyramid Place SE DECISION MADE: 18-MAR-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BBX-PET Scanner
Prescient Imaging, LLC 510(k) NO: K210450(Third Party - Traditional)
ATTN: Farhad Daghighian PHONE NO : 1 310 4284101
12569 Crenshaw Blvd SE DECISION MADE: 17-MAR-21
Hawthorne CA 90250 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPINEART Navigation Instrument System
Spineart 510(k) NO: K210472(Special)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 chemin du pré Fleuri SE DECISION MADE: 19-MAR-21
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPACT and X-Ranger
MinXray, Inc. 510(k) NO: K210479(Special)
ATTN: Keith Kretchmer PHONE NO : 847 5640323
3611 Commercial Avenue SE DECISION MADE: 19-MAR-21
Northbrook IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIPLNI YK-244 Disposable Surgical Mask
Hunan Yuankang Biological Technolo510(k) NO: K210487(Third Party - Traditional)
ATTN: Kylin Rui Chen PHONE NO : 86 135 60755999
Heping Team, Sanlian Community, XiSE DECISION MADE: 16-MAR-21
Hengyang CN 421000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Betta Link Knotless Implant System
T.A.G. Medical Products Corporatio510(k) NO: K210498(Special)
ATTN: Shlomi Dines PHONE NO : 972 4 9858400
Gaaton SE DECISION MADE: 24-MAR-21
Gaaton IL 2513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Cautery Tip Cleaner
Medline Industries, Inc. 510(k) NO: K210526(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
Three Lakes Drive SE DECISION MADE: 12-MAR-21
Northfield IL 60093 510(k) STATEMENT
DEVICE: GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Gramercy Extremity Orthopedics, LL510(k) NO: K210534(Special)
ATTN: Michael P. Simpson PHONE NO : 855 4362278
1239 N Glenville Dr SE DECISION MADE: 26-MAR-21
Richardson TX 75081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALO Grand Corded and Accessory Lenses
Ultradent Products, Inc 510(k) NO: K210550(Third Party - Traditional)
ATTN: Adam Black PHONE NO : 801 5724200
505 West Ultradent Drive (10200 SoSE DECISION MADE: 01-MAR-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Persona Revision Knee System
Zimmer, Inc. 510(k) NO: K210551(Special)
ATTN: Romil Sheth PHONE NO : 574 2688196
1800 W. Center Street SE DECISION MADE: 18-MAR-21
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7D Surgical System - Drill Guide
7D Surgical Inc. 510(k) NO: K210555(Special)
ATTN: Daniel Zisind PHONE NO : 647 4840079
60 scarsdale road, unit 118 SE DECISION MADE: 23-MAR-21
Toronto CA M3B 2R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEGION Porous CR Narrow Femoral Components
Smith & Nephew, Inc. 510(k) NO: K210566(Special)
ATTN: Michelle Huettner PHONE NO : 765 4266070
1450 Brooks Road SE DECISION MADE: 25-MAR-21
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SDC3 HD Information Management System with Wireless Device Control Capability
Stryker 510(k) NO: K210584(Special)
ATTN: Divya Sekar PHONE NO : 669 2044851
5900 Optical Ct SE DECISION MADE: 18-MAR-21
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Bair Hugger Temperature Management System (Model 675)
3M Company 510(k) NO: K210603(Special)
ATTN: Brian Kleiber PHONE NO : 651 7370195
3M Center, 2510 Conway Ave. Bldg. SE DECISION MADE: 30-MAR-21
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Longeviti PMMA Static Cranial Implant
Longeviti Neuro Solutions, LLC 510(k) NO: K210616(Special)
ATTN: Heather Hourihan PHONE NO : 410 5271803
303 International Circle Suite 190SE DECISION MADE: 31-MAR-21
Hunt Valley MD 21030 510(k) STATEMENT
DEVICE: Avitus(r) Bone Harvester
Avitus Orthopaedics, Inc. 510(k) NO: K210631(Special)
ATTN: Maxim Budyansky PHONE NO : 860 6379920
6 Amstrong Rd, Suite 107 SE DECISION MADE: 31-MAR-21
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-ED COIL System
Kaneka Medical America LLC 510(k) NO: K210638(Special)
ATTN: Audra Bogucki PHONE NO : 917 6289870
623 Fifth Avenue SE DECISION MADE: 26-MAR-21
New York NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnCor Breast Biopsy Probe with Rinse Tube
SenoRx, Inc. 510(k) NO: K210654(Special)
ATTN: Jessica Myer PHONE NO : 480 5978420
1625 West 3rd Street SE DECISION MADE: 31-MAR-21
Tempe AZ 85251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIREBIRD SI Fusion System
Orthofix Inc. 510(k) NO: K210667(Special)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 25-MAR-21
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIOnavi-Denture02
DIO Corporation 510(k) NO: K210828(Third Party - Traditional)
ATTN: Ji-Ae Park PHONE NO : 82 51 7457836
66, Centumseo-ro, Haeundae-gu, SE DECISION MADE: 23-MAR-21
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 270
TOTAL WITH SUMMARIES 254
TOTAL WITH STATEMENTS 16
