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FDA 510(k) Applications Submitted by Benjamin Rochette
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150091
01/16/2015
Versatex Monofilament Mesh
SOFRADIM PRODUCTION
K172395
08/08/2017
Duatene bilayer mesh
Sofradim Production
K192443
09/06/2019
Dextile Anatomical Mesh
Sofradim Production
K163212
11/16/2016
Parietene DS Composite Mesh
Sofradim Production
K173796
12/14/2017
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
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