510(k) K091516 ยท EZL Catheter, Retention Type, Balloon
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
| Applicant | Well Lead Medical Co., Ltd., Appollo Beach FL, US |
| Decision | Substantially Equivalent, Oct 16, 2009 |
| Received | May 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091516
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.