The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parie Tene Progrip Mesh.
| Device ID | K101197 |
| 510k Number | K101197 |
| Device Name: | PARIE TENE PROGRIP 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-28 |
| Decision Date | 2010-05-05 |
| Summary: | summary |