510(k) K051485 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
AMS PELVIC FLOOR REPAIR SYSTEM
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Aug 3, 2005 |
| Received | Jun 6, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051485
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.