510(k) K943960 ยท ESD Hearing Aid, Air-Conduction, Prescription
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS
| Applicant | Miracle-Ear, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent, Oct 20, 1994 |
| Received | Aug 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943960
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.