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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
510(k) Number K160960
Device Name EsophyX® Z Device with SerosaFuse Fasteners and Accessories
Applicant
Endogastric Solutions, Inc.
18109 NE 76th St. Suite 100
Redmond,  WA  98052
Applicant Contact STEVEN J HOFFMAN
Correspondent
Endogastric Solutions, Inc.
18109 NE 76th St. Suite 100
Redmond,  WA  98052
Correspondent Contact STEVEN J HOFFMAN
Regulation Number876.1500
Classification Product Code
ODE  
Date Received04/05/2016
Decision Date 05/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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