510(k) K211158 ยท OBR Mouthguard, Over-The-Counter
NTI ClenchGuard
| Applicant | Boyd Research, Inc., St Pete Beach FL, US |
| Decision | Substantially Equivalent, Sep 17, 2021 |
| Received | Apr 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211158
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.