The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietene Macroporous Mesh.
| Device ID | K223218 |
| 510k Number | K223218 |
| Device Name: | Parietene Macroporous Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Sofradim Production 116 Avenue Du Formans Trevoux, FR 01600 |
| Contact | Jhony Mallet |
| Correspondent | Wing Ng Covidien 15 Hampshire Street Mansfield, MA 02048 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-17 |
| Decision Date | 2022-12-02 |