510(k) K812864 ยท EWL Prosthesis, Laryngeal (Taub)
SILASTIC VOICE PROSTHESIS
| Applicant | Dow Corning Corp. Healthcare Industries Materials, Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 24, 1981 |
| Received | Oct 13, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812864
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.