K-number	K201866
Device name	NovaLine Tubing Sets for Hemodialysis
Applicant	Bain Medical Equipment (Guangzhou) Co., Ltd.
Product code	FJK
Device class	Class II
Decision date	Mar 10, 2021
Decision	Substantially Equivalent
Regulation	876.5820

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Source

View the full FDA submission: accessdata.fda.gov

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NovaLine Tubing Sets for Hemodialysis

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