510(k) K852052 ยท ESD Hearing Aid, Air-Conduction, Prescription
HEARING AID(ALL IN THE EAR(ALL IN THE CANAL
| Applicant | Penn-Tech Laboratories, Williamsport PA, US |
| Decision | Substantially Equivalent for Some Indications, Aug 16, 1985 |
| Received | May 9, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852052
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.