ClearanceBrief
510(k) K193522 ยท MQL Media, Reproductive

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

ApplicantKitazato Corporation, Fuji-Shi, JP
DecisionSubstantially Equivalent, Aug 25, 2020
ReceivedDec 19, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K193522

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.