510(k) K980919 ยท EZL Catheter, Retention Type, Balloon
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
| Applicant | Fortune Medical Instrument Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 31, 1998 |
| Received | Mar 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980919
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.