510(k) K831127 ยท ESE Larynx, Artificial (Battery-Powered)
INTRA-ORAL ARTIFICIAL LARYNX
| Applicant | Xomed, Inc., Arnold MO, US |
| Decision | Substantially Equivalent, Jul 28, 1983 |
| Received | Apr 6, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831127
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.