510(k) K881363 ยท KOD Catheter, Urological
SYRINGE PREFILLED WITH WATER
| Applicant | I M, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, Jun 23, 1988 |
| Received | Mar 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881363
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.