510(k) K221369 ยท OBR Mouthguard, Over-The-Counter
FBCC Night Guard
| Applicant | Fbcc, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Nov 18, 2022 |
| Received | May 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221369
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.