The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Composite Mono Pm Mesh.
| Device ID | K081126 |
| 510k Number | K081126 |
| Device Name: | PARIETEX COMPOSITE MONO PM 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 | Yes |
| Date Received | 2008-04-21 |
| Decision Date | 2008-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521177789 | K081126 | 000 |
| 10884521177772 | K081126 | 000 |
| 10884521177765 | K081126 | 000 |
| 10884521177758 | K081126 | 000 |