K-number	K192928
Device name	Optiflux Enexa F500 Dialyzer
Applicant	Fresenius Medical Care Reanal Therapies Group, LLC
Product code	KDI
Device class	Class II
Decision date	Jul 9, 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 Enexa F500 Dialyzer

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