K-number	K190459
Device name	Hemoflow F3 and F4 Dialyzers
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	FJI
Device class	Class II
Decision date	Aug 23, 2019
Decision	Substantially Equivalent
Regulation	876.5820

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View the full FDA submission: accessdata.fda.gov

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Hemoflow F3 and F4 Dialyzers

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