K-number	K153449
Device name	2008K2 Hemodialysis Machine
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	KDI
Device class	Class II
Decision date	Apr 26, 2016
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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2008K2 Hemodialysis Machine

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