510(k) K081613 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 17, 2008 |
| Received | Jun 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081613
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.