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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K233368
Device Name Allograft Delivery Device (OFAC-C)
Applicant
Bioventus, LLC
4721 Emperor Blvd., Suite 100
Durham,  NC  27703
Applicant Contact Shanna Hu
Correspondent
Bioventus, LLC
4721 Emperor Blvd., Suite 100
Durham,  NC  27703
Correspondent Contact Shanna Hu
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/02/2023
Decision Date 06/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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