510(k) K960101 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
ISLAND BIOSURGICAL BOLSTER
| Applicant | Island Biosurgical, Inc., Mercer Island WA, US |
| Decision | Substantially Equivalent, Dec 16, 1996 |
| Received | Jan 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960101
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.