K-number	K101839
Device name	KANEKA PHARMA AMERICA XPRESS-WAY RX
Applicant	Kaneka Pharma America, LLC
Product code	QEZ
Device class	Class II
Decision date	Oct 22, 2010
Decision	Substantially Equivalent
Regulation	870.5150

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View the full FDA submission: accessdata.fda.gov

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KANEKA PHARMA AMERICA XPRESS-WAY RX

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