K-number	K190612
Device name	EQUINOX Balloon Dilatation Catheter
Applicant	Dornier Medtech America, Inc.
Product code	EZN
Device class	Class II
Decision date	Dec 6, 2019
Decision	Substantially Equivalent
Regulation	876.5470

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Source

View the full FDA submission: accessdata.fda.gov

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EQUINOX Balloon Dilatation Catheter

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