510(k) K043138 ยท EWL Prosthesis, Laryngeal (Taub)
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
| Applicant | Atos Medical AB, Horby, SE |
| Decision | Substantially Equivalent, Nov 22, 2004 |
| Received | Nov 12, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043138
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.