510(k) K033691 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
SAFYRE VS AND SAFYRE T
| Applicant | Promedon, Hopkonton MA, US |
| Decision | Substantially Equivalent, Dec 19, 2003 |
| Received | Nov 24, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033691
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.