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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 K053562
Device Name ZIMMER COLLAGEN REPAIR PATCH
Applicant
Tissue Science Laboratories, Plc
1141 Clark St., Suite D
Covington,  GA  30014
Applicant Contact ANGELA BUNN
Correspondent
Tissue Science Laboratories, Plc
1141 Clark St., Suite D
Covington,  GA  30014
Correspondent Contact ANGELA BUNN
Regulation Number878.3300
Classification Product Code
FTM  
Date Received12/21/2005
Decision Date 06/23/2006
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
Predetermined Change
Control Plan Authorized		 No
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