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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name centrifuges (micro, ultra, refrigerated) for clinical use
510(k) Number BK050055
Tradename GenesisCS Component Concentrating System
Device Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Original Applicant
Perfusion Partners & Associates, Inc.
6227 foxfire lane
fort myers,  FL  33912
Regulation Number862.2050
Classification Product Code
Date Received09/22/2005
Decision Date 10/13/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No