K-number	K143303
Device name	Single Use Biliary Balloon Dilator
Applicant	Olympus Medical Systems Corp.
Product code	FGE
Device class	Class II
Decision date	Feb 27, 2015
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Single Use Biliary Balloon Dilator

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