510(k) K181099 ยท OBR Mouthguard, Over-The-Counter
Bright Guard
| Applicant | Koncept Innovators, LLC, Myrtle Beach SC, US |
| Decision | Substantially Equivalent, Jan 18, 2019 |
| Received | Apr 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181099
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.