510(k) K100995 ยท JOH Tube Tracheostomy And Tube Cuff
SHIKANI SPEAKING VALVE
| Applicant | Shikani Medical, LLC, Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jun 25, 2010 |
| Received | Apr 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100995
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.