510(k) K012628 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
| Applicant | Gynecare Center, Somerville NJ, US |
| Decision | Substantially Equivalent, Oct 26, 2001 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012628
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.