510(k) K911617 ยท EZL Catheter, Retention Type, Balloon
UROTECH CATHETER
| Applicant | Urotech U.S.A., Inc., Garden City NY, US |
| Decision | Substantially Equivalent, Feb 25, 1993 |
| Received | Apr 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911617
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.