K-number	K161505
Device name	DyeVert NG Contrast Modulation System
Applicant	Osprey Medical, Inc.
Product code	DXT
Device class	Class II
Decision date	Aug 3, 2016
Decision	Substantially Equivalent
Regulation	870.1650

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View the full FDA submission: accessdata.fda.gov

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DyeVert NG Contrast Modulation System

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