510(k) K904729 ยท EWL Prosthesis, Laryngeal (Taub)
BLOM-SINGER SHOWER GUARD
| Applicant | Helix Medical, Inc., Santa Barbera CA, US |
| Decision | Substantially Equivalent, Feb 28, 1991 |
| Received | Oct 17, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904729
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.