K-number	K213992
Device name	CombiSet Hemodialysis Blood Tubing Set
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	FJK
Device class	Class II
Decision date	May 31, 2023
Decision	Substantially Equivalent
Regulation	876.5820

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Source

View the full FDA submission: accessdata.fda.gov

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CombiSet Hemodialysis Blood Tubing Set

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