510(k) K191033 ยท OBR Mouthguard, Over-The-Counter
LunaGuard Nighttime Dental Protector
| Applicant | Mckeon Products, Warren MI, US |
| Decision | Substantially Equivalent, Aug 5, 2019 |
| Received | Apr 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191033
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.