510(k) K121562 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
ALTIS SINGLE INCISION CLING SYSTEM
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 5, 2012 |
| Received | May 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121562
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.