510(k) K932163 ยท EWL Prosthesis, Laryngeal (Taub)
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
| Applicant | Helix Medical, Inc., Santa Barbera CA, US |
| Decision | Substantially Equivalent, Dec 15, 1993 |
| Received | May 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932163
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.