The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Progrip Mesh.
| Device ID | K081050 |
| 510k Number | K081050 |
| Device Name: | PARIETEX PROGRIP MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Sharon Alexander |
| Correspondent | Sharon Alexander SOFRADIM PRODUCTION 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 | 2008-04-14 |
| Decision Date | 2008-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521177710 | K081050 | 000 |
| 10884521177703 | K081050 | 000 |
| 10884521177727 | K081050 | 000 |
| 10884521177697 | K081050 | 000 |
| 10884521177680 | K081050 | 000 |
| 10884521177673 | K081050 | 000 |