The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Virtue Male Sling System And Alexis(r) Wound Retractor Kit.
| Device ID | K111881 |
| 510k Number | K111881 |
| Device Name: | VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT |
| Classification | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Contact | Janell A Colley |
| Correspondent | Janell A Colley COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Product Code | OTM |
| Subsequent Product Code | GAD |
| Subsequent Product Code | KKX |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-01 |
| Decision Date | 2011-08-17 |
| Summary: | summary |