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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 BK230818
Tradename Dr. PRP
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
YTS Global Inc
7406 alban station ct
springfield,  VA  22150 2310
Regulation Number864.9245
Classification Product Code
ORG  
Date Received03/02/2023
Decision Date 05/31/2023
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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