510(k) K983000 ยท BTO Tube, Tracheostomy (W/Wo Connector)
CRICOTHYROTOMY TUBE
| Applicant | Polamedco, Inc., Marina Del Rey CA, US |
| Decision | Substantially Equivalent, Oct 27, 1999 |
| Received | Aug 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983000
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.