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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 K013625
Device Name PERMACOL
Applicant
Tissue Science Laboratories, Plc
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Tissue Science Laboratories, Plc
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number878.3300
Classification Product Code
FTM  
Date Received11/05/2001
Decision Date 01/17/2002
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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