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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
510(k) Number K151083
Device Name BioBridge Collagen Matrix
Applicant
Fibralign Corporation
32930 Alvarado-Niles Rd., Suite 350
Union City,  CA  94587
Applicant Contact Greg King
Correspondent
Experien Group, LLC
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact Ronald S Warren
Regulation Number878.3300
Classification Product Code
OWY  
Date Received04/22/2015
Decision Date 01/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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