510(k) K092203 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
OMNISURE URETHRAL SLING, MODEL OTK52
| Applicant | Mpathy Medical Devices, Ltd., Glasgow, GB |
| Decision | Substantially Equivalent, Aug 12, 2009 |
| Received | Jul 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092203
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.