510(k) K780583 ยท BTR Tube, Tracheal (W/Wo Connector)
FOME-CUF PVC
| Applicant | Bivona Medical Technologies, Mchenry IL, US |
| Decision | Substantially Equivalent, May 12, 1978 |
| Received | Apr 12, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780583
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.