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FDA 510(k) Applications Submitted by KIM FORCH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200530
03/02/2020
AMICUS Separator System
Fresenius Kabi AG
K180615
03/08/2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
Fresenius Kabi USA LLC
K141019
04/21/2014
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED
FENWAL, INC.
K111702
06/17/2011
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
FENWAL, INC.
K162462
09/02/2016
AMICUS Separator System, AMICUS Separator System; Refurbished
FRESENIUS KABI USA LLC
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