ClearanceBrief
510(k) K222492 ยท HDX Dilator, Vaginal

Hope&Her Vaginal Dilators

ApplicantLujena, Inc., El Cajon CA, US
DecisionSubstantially Equivalent, Jun 27, 2023
ReceivedAug 17, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K222492

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.