510(k) K915761 ยท EWL Prosthesis, Laryngeal (Taub)
BIVONA-COLORADO VOICE PROSTHESIS
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Jun 29, 1992 |
| Received | Dec 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915761
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.