K-number	K092710
Device name	PENTAX ED-3490TK, VIDEO DUODENOSCOPE
Applicant	Pentax Medical Company
Product code	FDT
Device class	Class II
Decision date	Dec 2, 2009
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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PENTAX ED-3490TK, VIDEO DUODENOSCOPE

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