K-number	K160960
Device name	EsophyX® Z Device with SerosaFuse Fasteners and Accessories
Applicant	Endogastric Solutions, Inc.
Product code	ODE
Device class	Class II
Decision date	May 1, 2016
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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EsophyX® Z Device with SerosaFuse Fasteners and Accessories

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