510(k) K042684 ยท BTO Tube, Tracheostomy (W/Wo Connector)
WELL LEAD TRACHEOSTOMY TUBE
| Applicant | Well Lead Medical Instruments, Apollo Beach FL, US |
| Decision | Substantially Equivalent, Feb 17, 2005 |
| Received | Sep 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042684
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.