K-number	K123262
Device name	OPTIFLUX ULTRA DIALYZER
Applicant	Fresenius Medical Care North America
Product code	KDI
Device class	Class II
Decision date	Jan 6, 2014
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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OPTIFLUX ULTRA DIALYZER

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