510(k) K812982 ยท EWL Prosthesis, Laryngeal (Taub)
BLOM-SINGER VOICE PROSTHESIS
| Applicant | Bivona Medical Technologies, Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 24, 1981 |
| Received | Oct 23, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812982
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.