ClearanceBrief
510(k) K153409 ยท FXX Mask, Surgical

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

ApplicantProtect U Guard, LLC, Safety Harbor FL, US
DecisionSubstantially Equivalent, Nov 15, 2016
ReceivedNov 25, 2015
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K153409

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.