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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
510(k) Number K080452
Device Name COLLAGEN TENDON WRAP
Applicant
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,  NJ  07417
Applicant Contact PEGGY HANSEN
Correspondent
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,  NJ  07417
Correspondent Contact PEGGY HANSEN
Regulation Number878.3300
Classification Product Code
FTM  
Date Received02/19/2008
Decision Date 05/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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