510(k) K100485 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
GYNECARE TVT EXACT CONTINENCE SYSTEM
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Mar 16, 2010 |
| Received | Feb 19, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100485
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.