The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Virtue Ventral Urethral Elevation Sling System, Model 50020.
| Device ID | K091152 |
| 510k Number | K091152 |
| Device Name: | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 |
| Classification | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Applicant | COLOPLAST A/S HOLTEDAM 1 Humlebaek, DK 3050 |
| Contact | Angela Byland |
| Correspondent | Angela Byland COLOPLAST A/S HOLTEDAM 1 Humlebaek, DK 3050 |
| Product Code | OTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-05-07 |
| Summary: | summary |