510(k) K082206 ยท EWL Prosthesis, Laryngeal (Taub)
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
| Applicant | Helix Medical, LLC, Carpinteria CA, US |
| Decision | Substantially Equivalent, Sep 4, 2008 |
| Received | Aug 5, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082206
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.