K-number	K192707
Device name	Optiflux F180NR Dialyzer
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	KDI
Device class	Class II
Decision date	Sep 21, 2020
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Optiflux F180NR Dialyzer

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