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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 BK200543
Tradename Ranfac Autologous Platelet Seperator
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Ranfac Corporation
30 doherty st
avon,  MA  02322
Regulation Number864.9245
Classification Product Code
ORG  
Date Received11/13/2020
Decision Date 02/24/2021
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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