510(k) K080363 ยท MAH Hearing Aid, Bone Conduction, Implanted
BAHA CORDELLE II
| Applicant | Cochlear Bone Anchored Systems AB, Englewood CO, US |
| Decision | Substantially Equivalent, Apr 10, 2008 |
| Received | Feb 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080363
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.