510(k) K991587 ยท EWL Prosthesis, Laryngeal (Taub)
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
| Applicant | Helix Medical, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Jun 25, 1999 |
| Received | May 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991587
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.