510(k) K190687 ยท LRK Device, Anti-Snoring
Twilite Appliance
| Applicant | Stephen J Harkins, Dds, PC, Tucson AZ, US |
| Decision | Substantially Equivalent, Jul 2, 2019 |
| Received | Mar 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190687
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.