510(k) K013355 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
SPARC SLING SYSTEM
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Oct 26, 2001 |
| Received | Oct 10, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013355
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.