510(k) K113496 ยท OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 14, 2012 |
| Received | Nov 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113496
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.