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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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