510(k) K110420 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
OPHIRA MINI SLING SYSTEM
| Applicant | Promedon S.A, Piscataway NJ, US |
| Decision | Substantially Equivalent, May 8, 2012 |
| Received | Feb 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110420
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.