510(k) K163509 ยท PNZ Eustachian Tube Balloon Dilation Device
XprESS ENT Dilation System
| Applicant | Entellus Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 5, 2017 |
| Received | Dec 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163509
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.