The following data is part of a premarket notification filed by Sofradim Production with the FDA for Modification To Parietex Composite (pco) Mesh.
| Device ID | K040998 |
| 510k Number | K040998 |
| Device Name: | MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Mary Mcnamara-cullinane, Rac |
| Correspondent | Mary Mcnamara-cullinane, Rac SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2004-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521178465 | K040998 | 000 |
| 10884521178458 | K040998 | 000 |
| 10884521178472 | K040998 | 000 |