The following data is part of a premarket notification filed by Sofradim Production with the FDA for 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).
| Device ID | K173796 |
| 510k 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) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Sofradim Production 116 Avenue Du Formans Trevoux, FR 01600 |
| Contact | Benjamin Rochette |
| Correspondent | Angela Van Arsdale Coviden 60 Middletown Avenue North Haven, CT 06473 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2018-03-09 |
| Summary: | summary |