The following data is part of a premarket notification filed by Sofradim Production with the FDA for Versatex Monofilament Mesh.
| Device ID | K150091 |
| 510k Number | K150091 |
| Device Name: | Versatex Monofilament Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 116 AVENUE DU FORMANS Trevoux, FR 01600 |
| Contact | Benjamin Rochette |
| Correspondent | Mary Mellows COVIDIEN(Surgical Solutions) 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 | 2015-01-16 |
| Decision Date | 2015-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521532649 | K150091 | 000 |
| 10884521532229 | K150091 | 000 |
| 10884521532236 | K150091 | 000 |
| 10884521532243 | K150091 | 000 |
| 10884521532250 | K150091 | 000 |
| 10884521532267 | K150091 | 000 |
| 10884521532274 | K150091 | 000 |
| 10884521532298 | K150091 | 000 |
| 20884521532615 | K150091 | 000 |
| 20884521532622 | K150091 | 000 |
| 20884521532639 | K150091 | 000 |
| 10884521532212 | K150091 | 000 |