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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number BK070069
Tradename Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System
Device Name Syringe, piston
Original Applicant
Arthrex, Inc.
1370 creekside boulevard
naples,  FL  34108
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/10/2007
Decision Date 12/12/2008
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
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
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