510(k) K061459 ยท KLW Masker, Tinnitus
TRANQUIL TRI-BTE
| Applicant | General Hearing Instruments, Inc., New Orleans LA, US |
| Decision | Substantially Equivalent, Jun 30, 2006 |
| Received | May 26, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061459
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.