510(k) K233434 · LRK Device, Anti-Snoring
Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)
| Applicant | Prismatik Dentalcraft, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 14, 2023 |
| Received | Oct 13, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233434
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.