The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Polyester Mesh With Introducer.
| Device ID | K071629 |
| 510k Number | K071629 |
| Device Name: | PARIETEX POLYESTER MESH WITH INTRODUCER |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION HEALTHCARE GROUP 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Renee Borgesano |
| Correspondent | Renee Borgesano SOFRADIM PRODUCTION HEALTHCARE GROUP 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-14 |
| Decision Date | 2007-07-10 |
| Summary: | summary |