K-number	K122924
Device name	CRE FIXED WIRE BALLON DILATION CATHETER
Applicant	Boston Scientific Corp
Product code	KNQ
Device class	Class II
Decision date	Oct 24, 2012
Decision	Substantially Equivalent
Regulation	876.5365

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Source

View the full FDA submission: accessdata.fda.gov

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CRE FIXED WIRE BALLON DILATION CATHETER

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