510(k) K945407 ยท BTO Tube, Tracheostomy (W/Wo Connector)
SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
| Applicant | Mallinckrodt Medical Tpi, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 27, 1995 |
| Received | Nov 3, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945407
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.