510(k) K971244 ยท EWL Prosthesis, Laryngeal (Taub)
PROVOX 2 VOICE PROSTHESIS SYSTEM
| Applicant | Atos Medical AB, Horby, Sweden, SE |
| Decision | Substantially Equivalent, Jun 6, 1997 |
| Received | Apr 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971244
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.