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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 BK200477
Tradename Amplifine Gel Separator Tubes
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Suneva Medical, Inc.
5870 pacific center blvd
san diego,  CA  92121
Regulation Number864.9245
Classification Product Code
ORG  
Date Received04/10/2020
Decision Date 09/30/2020
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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