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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
Original Applicant
TISSUE SCIENCE LABORATORIES, PLC
7124 la jolla blvd.
la jolla,  CA 
Original Contact allison f wren
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/30/1999
Decision Date 02/17/2000
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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