510(k) K945554 ยท EMX Balloon, Epistaxis
EPISTAXIS BALLOON CATHETER WITH PACKING
| Applicant | Ultracell Medical Technologies, Inc., Old Mystic CT, US |
| Decision | Substantially Equivalent, Feb 17, 1995 |
| Received | Nov 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945554
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.