510(k) K111881 ยท OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 17, 2011 |
| Received | Jul 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111881
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.