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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 K142908
Device Name Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
Applicant
Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Applicant Contact Eric Jague
Correspondent
Surgical Devices, A Global Business Unit of Covidien
60 Middleton Ave.
North Haven,  CT  06473
Correspondent Contact Mary Mellows
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/06/2014
Decision Date 11/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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