510(k) K203606 ยท LRK Device, Anti-Snoring
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
| Applicant | Meris Investment Group, Lakeland MN, US |
| Decision | Substantially Equivalent, Mar 10, 2021 |
| Received | Dec 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203606
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.