510(k) K193577 ยท OBR Mouthguard, Over-The-Counter
SleepRight ProRx Custom Dental Guard
| Applicant | Splintek, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Jun 1, 2020 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193577
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.