510(k) K082815 ยท EZL Catheter, Retention Type, Balloon
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
| Applicant | Well Lead Medical Instruments, Guangzhou City, CN |
| Decision | Substantially Equivalent, Oct 8, 2008 |
| Received | Sep 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082815
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.