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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 K982532
Device Name PARIETEX
Original Applicant
COGENT
555 thirteenth st. n.w.
washington,  DC  20004
Original Contact howard m holstein
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/20/1998
Decision Date 01/20/1999
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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