510(k) K101297 ยท OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 3, 2010 |
| Received | May 10, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101297
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.