510(k) K854443 ยท KOD Catheter, Urological
O'NEIL URINARY CATHETER INTRODUCER
| Applicant | Pennine Medical , Ltd., Stoughton MA, US |
| Decision | Substantially Equivalent, Jan 8, 1986 |
| Received | Nov 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854443
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.