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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name platelet and plasma separator for bone graft handling
510(k) Number BK110040
Tradename Clotalyst Kit with GPS(R)III Separator
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Biomet Biologics, Inc.
56 east bell drive
po box 587
warsaw,  IN  46581 0587
Regulation Number864.9245
Classification Product Code
ORG  
Date Received07/25/2011
Decision Date 12/23/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
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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