510(k) K982042 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
| Applicant | Island Biosurgical, Inc., Mercer Island WA, US |
| Decision | Substantially Equivalent, Sep 8, 1998 |
| Received | Jun 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982042
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.