The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Plug And Patch.
| Device ID | K101519 |
| 510k Number | K101519 |
| Device Name: | PARIETEX PLUG AND PATCH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 15 CROSBY DRIVE Bedford, MA 01730 |
| Contact | James Mcmahon |
| Correspondent | James Mcmahon SOFRADIM PRODUCTION 15 CROSBY DRIVE Bedford, MA 01730 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-02 |
| Decision Date | 2010-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521176451 | K101519 | 000 |
| 20884521176444 | K101519 | 000 |
| 30884521176434 | K101519 | 000 |
| 30884521176427 | K101519 | 000 |