510(k) K150453 ยท EGJ Device, Iontophoresis, Other Uses
TULA Iontophoresis System with Earset
| Applicant | Acclarent, Inc., Rmenlo Park CA, US |
| Decision | Substantially Equivalent, May 20, 2015 |
| Received | Feb 20, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150453
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.