K-number	K021276
Device name	FG-36UX FIBER ULTRASOUND GASTROSCOPE
Applicant	Pentax Precision Instrument Corp.
Product code	ODG
Device class	Class II
Decision date	Sep 12, 2002
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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FG-36UX FIBER ULTRASOUND GASTROSCOPE

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