K-number	K011909
Device name	ULTRA-THIN SDS BALLOON DILATATION CATHETER
Applicant	Boston Scientific Corp
Product code	FGE
Device class	Class II
Decision date	Nov 28, 2001
Decision	Substantially Equivalent
Regulation	876.5010

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View the full FDA submission: accessdata.fda.gov

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ULTRA-THIN SDS BALLOON DILATATION CATHETER

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