The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Supris Retropubic Sling System.
| Device ID | K111233 |
| 510k Number | K111233 |
| Device Name: | SUPRIS RETROPUBIC SLING SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-06-24 |
| Summary: | summary |