510(k) K945287 ยท EWL Prosthesis, Laryngeal (Taub)
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
| Applicant | Helix Medical, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 9, 1994 |
| Received | Oct 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945287
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.