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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name syringe, piston
510(k) Number BK080004
Tradenames Clotalyst and GPS III Mini Platelet Concentrate Separation Kit with ACD-A, Clotalyst and GPS III Platelet Concentrate Separation Kit with ACD-A
Device Name Syringe, piston
Original Applicant
Biomet Biologics, Inc.
56 east bell drive
po box 587
warsaw,  IN  46581 0587
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/04/2008
Decision Date 09/14/2017
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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