510(k) K963822 ยท ESD Hearing Aid, Air-Conduction, Prescription
OVATION AGC-3
| Applicant | Orsonique, Inc., Laval, Quebec, CA |
| Decision | Substantially Equivalent, Oct 28, 1996 |
| Received | Sep 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963822
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.