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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact