510(k) K001583 ยท KOD Catheter, Urological
ISLAND BIOSURGICAL BNS KIT #3
| Applicant | Island Biosurgical, LLC, Mercer Island WA, US |
| Decision | Substantially Equivalent, Jul 13, 2000 |
| Received | May 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001583
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.