510(k) K093258 ยท EWL Prosthesis, Laryngeal (Taub)
BLOM-SINGER INDWELLING TEP OCCLUDER
| Applicant | Helix Medical, LLC, Carpinteria CA, US |
| Decision | Substantially Equivalent, Mar 3, 2010 |
| Received | Oct 19, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093258
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.