FDA 510(k) Applications Submitted by Kristen Bozzelli

FDA 510(k) Number Submission Date Device Name Applicant
K201809 07/01/2020 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory Baxter Healthcare Corportation
K232467 08/15/2023 CleanCart A, CleanCart C, AK 98 Hemodialysis Machine Baxter Healthcare Corporation
DEN190042 09/16/2019 Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer Baxter Healthcare Corporation
K162887 10/17/2016 PrismaSATE Baxter Healthcare Corporation


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