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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 K173796
Device Name Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
Sofradim Production
116 avenue du Formans
Trevoux,  FR 01600
Applicant Contact Benjamin Rochette
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Angela Van Arsdale
Regulation Number878.3300
Classification Product Code
Date Received12/14/2017
Decision Date 03/09/2018
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
Recalls CDRH Recalls