K160960

Substantially Equivalent

EsophyX® Z Device with SerosaFuse Fasteners and Accessories

Applicant: Endogastric Solutions, Inc.
Product code: ODE
Advisory panel: Gastroenterology, Urology
Date received: 2016-04-05
Decision date: 2016-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, US

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