Name: Predicase
Price: 199 USD

K-number	K130247
Device name	PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
Applicant	Pentax of America, Inc.
Product code	ODG
Device class	Class II
Decision date	Mar 20, 2013
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

Everything you need for a 510(k) submission. Nothing you don't.