K-number	K971320
Device name	CRE BALLOON DILATATION CATHETER
Applicant	Boston Scientific Corp
Product code	KNQ
Device class	Class II
Decision date	Oct 9, 1997
Decision	Substantially Equivalent
Regulation	876.5365

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View the full FDA submission: accessdata.fda.gov

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CRE BALLOON DILATATION CATHETER

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