510(k) K940638 ยท EWL Prosthesis, Laryngeal (Taub)
PROVOX(TM) VOICE PROSTHESIS
| Applicant | Atos Medical AB, Horby, Sweden, SE |
| Decision | Substantially Equivalent, Jun 22, 1994 |
| Received | Feb 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940638
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.