510(k) K884427 ยท BTO Tube, Tracheostomy (W/Wo Connector)
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Nov 2, 1988 |
| Received | Oct 20, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884427
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.