510(k) K121805 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
AMS LARGE PORE POLYPROPHLENE MESH
| Applicant | American Medical Systems, Minnetonka MN, US |
| Decision | Substantially Equivalent, Oct 16, 2012 |
| Received | Jun 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121805
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.