510(k) K912967 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Jul 17, 1991 |
| Received | Jul 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912967
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.