The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietene Duo And Quadra Polypropylene Meshes.
| Device ID | K072951 |
| 510k Number | K072951 |
| Device Name: | PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | SOFRADIM PRODUCTION 150 GLOVER AVENUE Norwalk, CT 06856 |
| Contact | Sharon Alexander |
| Correspondent | Sharon Alexander SOFRADIM PRODUCTION 150 GLOVER AVENUE Norwalk, CT 06856 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-18 |
| Decision Date | 2007-12-19 |
| Summary: | summary |