FDA 510(k), K173796, 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)

FDA 510(k), K173796, 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)

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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)
Manufacturer: Benjamin Rochette
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: 12/14/2017
Date Received: 03/09/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

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