The following data is part of a premarket notification filed by Sofradim Production with the FDA for Progrip Laparscopic Self-fixating Mesh.
| Device ID | K120897 |
| 510k Number | K120897 |
| Device Name: | PROGRIP LAPARSCOPIC SELF-FIXATING MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 15 CROSBY DRIVE Bedford, MA 01730 |
| Contact | James Mcmahon |
| Correspondent | James Mcmahon SOFRADIM PRODUCTION 15 CROSBY DRIVE Bedford, MA 01730 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-26 |
| Decision Date | 2012-06-29 |