510(k) K140278 ยท LRK Device, Anti-Snoring
SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
| Applicant | Somnomed, Inc., Frisco TX, US |
| Decision | Substantially Equivalent, Jun 20, 2014 |
| Received | Feb 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140278
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.