510(k) Report

Devices descending from K223551

1 later device reach Sterile Water for Inhalation in 1L Flexoval ® bottles. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.20250—