ClearanceBrief
510(k) K061864 ยท FXX Mask, Surgical

DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560

ApplicantDukal Corp., Hauppauge NY, US
DecisionSubstantially Equivalent, Sep 15, 2006
ReceivedJul 3, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K061864

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.