510(k) K100360 ยท LXB Hearing Aid, Bone Conduction
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
| Applicant | Cochlear Americas, Centennial CO, US |
| Decision | Substantially Equivalent, Jul 13, 2010 |
| Received | Feb 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100360
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.