ClearanceBrief
510(k) K230495 ยท MQC Mouthguard, Prescription

Serena Sleep Night Guard

ApplicantMeris Investment Group, Lakeland MN, US
DecisionSubstantially Equivalent, Oct 13, 2023
ReceivedFeb 23, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K230495

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.