510(k) Report

Devices descending from K113033

3 later devices reach Sodium Chlorde Inhalation Solution, 0.9% Usp-3ML through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142153Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLTeleflexmedical, Inc.20151Class I
+1K130091PulmosalPharmacaribe201301
+2K231058Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP20240—