K-number	K191313
Device name	Unity Subcutaneous Infusion System for Remodulin
Applicant	DEKA Research & Development
Product code	QJY
Device class	Class II
Decision date	Feb 21, 2020
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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Unity Subcutaneous Infusion System for Remodulin

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