510(k) Report

Devices descending from K232777

1 later device reach FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.20250—