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In this section: Substantially Equivalent 510(k) Device Information

BK190368 - Aurora Plasmapheresis System, Software Version 2.1

510(k) Number: BK190368
Applicant: Fresenius Kabi AG
Device Name: Aurora Plasmapheresis System, Software Version 2.1
Decision Date: 7/26/2019

Supporting Documents

BK190368 Letter
BK190368 Summary

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