510(k) K053429 ยท EZL Catheter, Retention Type, Balloon
ADVANCED UROLOGICAL CATHETER
| Applicant | Entracare, LLC, Lenexa KS, US |
| Decision | Substantially Equivalent, Feb 8, 2006 |
| Received | Dec 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053429
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.