510(k) K920657 ยท ESD Hearing Aid, Air-Conduction, Prescription
DI CUSTOM IN THE EAR AND IN THE CANAL
| Applicant | Dakota Laboratories, Inc., Lake Andes SD, US |
| Decision | Substantially Equivalent, Mar 31, 1992 |
| Received | Feb 12, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920657
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.