510(k) Report

Devices descending from K160271

1 later device reach N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.20180—