510(k) K172223 ยท OBR Mouthguard, Over-The-Counter
SleepRight ProRx Custom Dental Guard
| Applicant | Splintek, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Nov 17, 2017 |
| Received | Jul 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172223
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.