The following data is part of a premarket notification filed by Sofradim Production with the FDA for Uretex Sup Pubourethral Sling.
| Device ID | K012949 |
| 510k Number | K012949 |
| Device Name: | URETEX SUP PUBOURETHRAL SLING |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2001-10-04 |
| Summary: | summary |