ClearanceBrief
510(k) K231865 ยท OBR Mouthguard, Over-The-Counter

Mouth Guard (ATG0603R)

ApplicantReazeal Corp, Wilmington DE, US
DecisionSubstantially Equivalent, Nov 6, 2023
ReceivedJun 26, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231865

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.