510(k) K100807 ยท PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Jun 7, 2010 |
| Received | Mar 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100807
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.