K-number	K150142
Device name	Single Use Balloon Dilator V (with Knife)
Applicant	Olympus Medical Systems Corp.
Product code	KNS
Device class	Class II
Decision date	Oct 8, 2015
Decision	Substantially Equivalent
Regulation	876.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Single Use Balloon Dilator V (with Knife)

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