510(k) K900548 ยท BTO Tube, Tracheostomy (W/Wo Connector)
SHILEY PHONATION VALVE
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 23, 1990 |
| Received | Feb 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900548
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.