510(k) K861088 ยท EWL Prosthesis, Laryngeal (Taub)
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Apr 2, 1986 |
| Received | Mar 21, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861088
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.