510(k) K021263 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
MODIFICATION TO SPARC SLING SYSTEM
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, May 15, 2002 |
| Received | Apr 22, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021263
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.