The following data is part of a premarket notification filed by Sofradim Production with the FDA for Ugytex Sual Knit Mesh.
| Device ID | K051503 |
| 510k Number | K051503 |
| Device Name: | UGYTEX SUAL KNIT MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | OTP |
| Subsequent Product Code | OTO |
| Subsequent Product Code | PAI |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-07 |
| Decision Date | 2005-08-05 |
| Summary: | summary |