K-number	K113769
Device name	GPSCATH BALLON DILATATION CATHETER
Applicant	Hotspur Technologies
Product code	LIT
Device class	Class II
Decision date	Jan 20, 2012
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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GPSCATH BALLON DILATATION CATHETER

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