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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
FOIA Releasable 510(k) K982532
Device Name PARIETEX
Applicant
Cogent
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Cogent
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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