K-number	K161222
Device name	PENTAX MEDICAL ED-3490TK, Video Duodenoscope
Applicant	Pentax Medical
Product code	FDT
Device class	Class II
Decision date	Feb 7, 2018
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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PENTAX MEDICAL ED-3490TK, Video Duodenoscope

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