510(k) K020007 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
SAFYRE SLING SYSTEM
| Applicant | Promedon, Essex Junction VT, US |
| Decision | Substantially Equivalent, Mar 21, 2002 |
| Received | Jan 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020007
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.