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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 K163212
Device Name Parietene DS Composite Mesh
Applicant
Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Applicant Contact Benjamin Rochette
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Mary Mellows
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/16/2016
Decision Date 06/29/2017
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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