510(k) K930105 ยท EWL Prosthesis, Laryngeal (Taub)
BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.
| Applicant | Helix Medical, Inc., Santa Barbera CA, US |
| Decision | Substantially Equivalent, May 17, 1993 |
| Received | Jan 11, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930105
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.