K-number	K162462
Device name	AMICUS Separator System, AMICUS Separator System; Refurbished
Applicant	Fresenius Kabi USA,Llc
Product code	GKT
Device class	Class II
Decision date	Nov 23, 2016
Decision	Substantially Equivalent
Regulation	864.9245

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View the full FDA submission: accessdata.fda.gov

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AMICUS Separator System, AMICUS Separator System; Refurbished

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