K-number	K153384
Device name	Low Potassium Dextran Solution with Tris Diluent
Applicant	United Therapeutics Corporation
Product code	KDN
Device class	Class II
Decision date	Feb 19, 2016
Decision	Substantially Equivalent
Regulation	876.5880

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Source

View the full FDA submission: accessdata.fda.gov

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Low Potassium Dextran Solution with Tris Diluent

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