ClearanceBrief
510(k) K111616 ยท EKX Handpiece, Direct Drive, Ac-Powered

E-CUBE

ApplicantSaeshin Precision Co., Ltd., Daegu, KR
DecisionSubstantially Equivalent, Aug 19, 2011
ReceivedJun 10, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K111616

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.