510(k) K900583 ยท EMX Balloon, Epistaxis
MODIFIED BIVONA EPISTAXIS CATHETER
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Aug 9, 1990 |
| Received | Feb 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900583
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.