The following data is part of a premarket notification filed by Sofradim Production with the FDA for Progrip Laparoscopic Self-fixating Mesh.
| Device ID | K143386 |
| 510k Number | K143386 |
| Device Name: | Progrip Laparoscopic Self-Fixating Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 116 AVENUE DU FORMANS Trevoux, FR 01600 |
| Contact | Eric Jague |
| Correspondent | Mary Mellows Surgical Devices, A Global Business Unit Of Covidien 60 Middleton Avenue 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 | 2014-11-26 |
| Decision Date | 2015-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521513242 | K143386 | 000 |
| 10884521513235 | K143386 | 000 |
| 10884521513228 | K143386 | 000 |
| 10884521513211 | K143386 | 000 |
| 10884521513204 | K143386 | 000 |
| 10884521513198 | K143386 | 000 |