K-number	K160444
Device name	FB-U Hemodialyzer
Applicant	Nipro Medical Corporation
Product code	KDI
Device class	Class II
Decision date	Feb 8, 2017
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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FB-U Hemodialyzer

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