Name: Predicase
Price: 199 USD

K-number	K183683
Device name	FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
Applicant	Fujifilm Corporation
Product code	FDA
Device class	Class II
Decision date	Feb 27, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5

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