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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 BK190406
Tradename Arthrex Double Syringe (ACP) System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Arthrex, Inc.
1370 creekside boulevard
naples,  FL  34108
Regulation Number864.9245
Classification Product Code
ORG  
Date Received10/07/2019
Decision Date 11/06/2019
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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