K-number	K050502
Device name	SINGLE USE BALLOON DILATOR MAXPASSTM
Applicant	Olympus Winter & Ibe GmbH
Product code	FGE
Device class	Class II
Decision date	Jul 8, 2005
Decision	Substantially Equivalent
Regulation	876.5010

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View the full FDA submission: accessdata.fda.gov

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SINGLE USE BALLOON DILATOR MAXPASSTM

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