510(k) K132655 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
RETROARC RETROPUBIC SLING SYSTEM
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Nov 20, 2013 |
| Received | Aug 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132655
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.