K-number	K152367
Device name	Optiflux dialyzer
Applicant	Fresenius Medical Care North America
Product code	KDI
Device class	Class II
Decision date	Oct 29, 2015
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Optiflux dialyzer

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