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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, polymeric
510(k) Number K043366
Device Name PERMACOL SURGICAL IMPLANT
Applicant
TISSUE SCIENCE LABORATORIES, PLC
1141 CLARK STREET, SUITE D
COVINGTON,  GA  30014
Applicant Contact VICTORIA TAYLOR
Correspondent
TISSUE SCIENCE LABORATORIES, PLC
1141 CLARK STREET, SUITE D
COVINGTON,  GA  30014
Correspondent Contact VICTORIA TAYLOR
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/08/2004
Decision Date 12/17/2004
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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