510(k) K040538 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Mar 17, 2004 |
| Received | Mar 2, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040538
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.