K-number	K162434
Device name	NC Gallant PTCA Catheter
Applicant	Medinol, Ltd.
Product code	LOX
Device class	Class II
Decision date	Jan 19, 2017
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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NC Gallant PTCA Catheter

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