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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K260711
Device Name Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)
Applicant
Berkeley Advanced Biomaterials
2800 Seventh St.
Berkeley,  CA  94710
Applicant Contact Bradley Glover
Correspondent
Berkeley Advanced Biomaterials
2800 Seventh St.
Berkeley,  CA  94710
Correspondent Contact Bradley Glover
Classification Product Code
KGN  
Date Received03/05/2026
Decision Date 08/27/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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