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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 BK190317
Tradename PurePRP® SupraPhysiologic Concentrating System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
EmCyte Corporation
4331 veronica south shoemaker blvd
for myers,  FL  33916
Regulation Number864.9245
Classification Product Code
ORG  
Date Received02/11/2019
Decision Date 02/12/2020
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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