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FDA 510(k) Applications Submitted by FRESENIUS KABI USA LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
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
K162462
09/02/2016
AMICUS Separator System, AMICUS Separator System; Refurbished
FRESENIUS KABI USA LLC
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