510(k) K010006 ยท EZL Catheter, Retention Type, Balloon
DRAINAGE CATHETER OR FOLEY CATHETER
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Jul 25, 2001 |
| Received | Jan 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010006
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.