510(k) K973022 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
| Applicant | Island Biosurgical, Inc., Mercer Island WA, US |
| Decision | Substantially Equivalent, Oct 20, 1997 |
| Received | Aug 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973022
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.