510(k) K881011 ยท EWL Prosthesis, Laryngeal (Taub)
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, May 13, 1988 |
| Received | Mar 10, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881011
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.