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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 BK130068
Tradename SmartPrep2 System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Harvest Technologies Corp
40 grissom road
plymouth,  MA  02360
Regulation Number864.9245
Classification Product Code
ORG  
Date Received10/28/2013
Decision Date 03/24/2014
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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