510(k) K823118 ยท ESE Larynx, Artificial (Battery-Powered)
SAY
| Applicant | Kells Medical, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 7, 1983 |
| Received | Oct 21, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823118
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.