510(k) K821584 ยท EMX Balloon, Epistaxis
EPISTAXIS CATHETER/KIT
| Applicant | Bivona Medical Technologies, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 14, 1982 |
| Received | Jun 1, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821584
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.