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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 BK100066
Tradename ThermoGenesis Res-Q60 PRP Device
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Thermogenesis
2711 citrus road
rancho cordova,  CA  95742
Regulation Number864.9245
Classification Product Code
ORG  
Date Received11/22/2010
Decision Date 05/27/2011
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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