510(k) K914183 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA CUFF MAINTENANCE DEVICE (CMD)
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Oct 23, 1991 |
| Received | Sep 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914183
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.