510(k) K853967 ยท ESD Hearing Aid, Air-Conduction, Prescription
HI-TECH LAB MODEL CONCHA ALL IN EAR
| Applicant | Hi-Tech Laboratories, Inc., Blue Springs MO, US |
| Decision | Substantially Equivalent, Dec 27, 1985 |
| Received | Sep 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853967
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.