The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Composite Ventral Patch.
| Device ID | K120506 |
| 510k Number | K120506 |
| Device Name: | PARIETEX COMPOSITE VENTRAL PATCH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 15 CROSBY DR Bedford, MA 01730 |
| Contact | James Mcmahon |
| Correspondent | James Mcmahon SOFRADIM PRODUCTION 15 CROSBY DR 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 | 2012-02-21 |
| Decision Date | 2012-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521165724 | K120506 | 000 |
| 10884521514164 | K120506 | 000 |
| 10884521514157 | K120506 | 000 |
| 10884521514140 | K120506 | 000 |
| 10884521165717 | K120506 | 000 |
| 10884521165700 | K120506 | 000 |