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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 BK251248
Tradenames PRiSM PRP, 10 mL (PRP10), PRiSM PRP, 20 mL (PRP20), PRiSM PRP, 30 mL (PRP30), PRiSM PRP, 40 mL (PRP40)
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Bahia Medical
7250 dallas parkway
suite 400
plano,  TX  75024
Regulation Number864.9245
Classification Product Code
ORG  
Date Received07/15/2025
Decision Date 12/23/2025
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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