K-number	K233557
Device name	HemoCare Hemodialysis System
Applicant	Deka Research and Development
Product code	KDI
Device class	Class II
Decision date	Jul 12, 2024
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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HemoCare Hemodialysis System

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