510(k) K012949 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
URETEX SUP PUBOURETHRAL SLING
| Applicant | Sofradim Production, Ayer MA, US |
| Decision | Substantially Equivalent, Oct 4, 2001 |
| Received | Sep 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012949
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.