510(k) DEN150056 ยท PNZ Eustachian Tube Balloon Dilation Device
Acclarent Aera Eustachian Tube Balloon Dilation System
| Applicant | Acclarent, Inc., Rmenlo Park CA, US |
| Decision | Unknown, Sep 16, 2016 |
| Received | Dec 7, 2015 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN150056
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.