510(k) K852272 ยท BTO Tube, Tracheostomy (W/Wo Connector)
BIVONA TRACHEOSTOMA VALVE II
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Jul 8, 1985 |
| Received | May 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852272
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.