K-number	K182940
Device name	Surdial DX Hemodialysis System
Applicant	Nipro Medical Corporation
Product code	KDI
Device class	Class II
Decision date	Jul 19, 2019
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Surdial DX Hemodialysis System

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