The following data is part of a premarket notification filed by Sofradim Production with the FDA for Progrip Self-gripping Polypropylene Mesh, Parietene Flat Sheet Mesh.
| Device ID | K140941 |
| 510k Number | K140941 |
| Device Name: | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 60 MIDDLETON AVE North Haven, CT 06473 |
| Contact | Clare Santulli |
| Correspondent | Clare Santulli SOFRADIM PRODUCTION 60 MIDDLETON AVE North Haven, CT 06473 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521177666 | K140941 | 000 |
| 10884521177659 | K140941 | 000 |
| 10884521177635 | K140941 | 000 |