The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Monofilament Polyester Mesh (new Name: Parietex Lightweight Mesh), Parietex Composite Mono Pm Mesh (new Name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh.
| Device ID | K142908 |
| 510k Number | K142908 |
| Device Name: | Parietex Monofilament Polyester Mesh (new Name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new Name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 116 AVENUE DU FORMANS Trevoux, FR 01600 |
| Contact | Eric Jague |
| Correspondent | Mary Mellows Surgical Devices, A Global Business Unit Of Covidien 60 Middleton Avenue North Haven, CT 06473 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-06 |
| Decision Date | 2014-11-14 |
| Summary: | summary |