The following data is part of a premarket notification filed by Sofradim Production with the FDA for Symbotex Composite Mesh, Progrip Self-gripping Polyester Mesh, Parietex Hydrophilic 2d 3d Anatomical Mesh, Versatex Monofilament Mesh.
| Device ID | K220586 |
| 510k Number | K220586 |
| Device Name: | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Sofradim Production 116, Avenue Du Formans Trevoux, FR 01600 |
| Contact | Paula Paz |
| Correspondent | Wing Ng Covidien LLC. 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 | 2022-03-01 |
| Decision Date | 2022-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521180352 | K220586 | 000 |
| 10884521180161 | K220586 | 000 |
| 10884521180154 | K220586 | 000 |
| 10884521180147 | K220586 | 000 |
| 10884521180130 | K220586 | 000 |
| 10884521180093 | K220586 | 000 |
| 10884521180055 | K220586 | 000 |
| 10884521180031 | K220586 | 000 |
| 10884521180017 | K220586 | 000 |
| 10884521180000 | K220586 | 000 |
| 10884521179974 | K220586 | 000 |
| 10884521179967 | K220586 | 000 |
| 10884521180185 | K220586 | 000 |
| 10884521180208 | K220586 | 000 |
| 10884521180345 | K220586 | 000 |
| 10884521180321 | K220586 | 000 |
| 10884521180314 | K220586 | 000 |
| 10884521180291 | K220586 | 000 |
| 10884521180284 | K220586 | 000 |
| 10884521180277 | K220586 | 000 |
| 10884521180260 | K220586 | 000 |
| 10884521180253 | K220586 | 000 |
| 10884521180239 | K220586 | 000 |
| 10884521180222 | K220586 | 000 |
| 10884521180215 | K220586 | 000 |
| 10884521180062 | K220586 | 000 |