510(k) Forms
List of forms associated with Premarket Notification (510[k]) submissions
- Acceptance Checklists for Traditional, Abbreviated, and Special 510(k)s
- Premarket Notification Class III Certification and Summary
- Premarket Notification Truthful And Accurate Statement
- Premarket Notification 510(k) Statement
- Exempt Device Review Form (PDF - 16KB)
- 510(k) Cover Sheet Memorandum (PDF - 41KB)
- 510(k) "Substantial Equivalence" Decision Making Process (PDF - 844KB)
- Indications for Use (PDF - 1.7MB)
- Required Elements for a Declaration of Conformity to a Recognized Standard