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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 K992556
Device Name PERMACOL
Applicant
TISSUE SCIENCE LABORATORIES, PLC
7124 LA JOLLA BLVD.
LA JOLLA,  CA 
Applicant Contact ALLISON F WREN
Correspondent
TISSUE SCIENCE LABORATORIES, PLC
7124 LA JOLLA BLVD.
LA JOLLA,  CA 
Correspondent Contact ALLISON F WREN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/30/1999
Decision Date 02/17/2000
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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