510(k) K201484 ยท LRK Device, Anti-Snoring
Somnos Anti-Snoring Mouth Guard
| Applicant | Koncept Innovators, LLC, Myrtle Beach SC, US |
| Decision | Substantially Equivalent, Nov 23, 2020 |
| Received | Jun 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201484
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.