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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 K143645
Device Name EsophyX® Z Fastener Delivery Device
Applicant
Endogastric Solutions, Inc.
18109 NE 76th St. Suite 100
Redmond,  WA  98052
Applicant Contact DARREN CROW
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 Received12/22/2014
Decision Date 03/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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