ClearanceBrief
510(k) K220917 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

ApplicantGri-Alleset, Inc., Flowery Branch GA, US
DecisionSubstantially Equivalent, May 18, 2022
ReceivedMar 30, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K220917

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.