K-number	K112701
Device name	CHARGER BALLOON DILATATION CATHETER
Applicant	Boston Scientific
Product code	FGE
Device class	Class II
Decision date	Oct 25, 2011
Decision	Substantially Equivalent
Regulation	876.5010

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View the full FDA submission: accessdata.fda.gov

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CHARGER BALLOON DILATATION CATHETER

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