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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 STREET SUITE 100
REDMOND,  WA  98052
Applicant Contact STEVEN J HOFFMAN
Correspondent
ENDOGASTRIC SOLUTIONS, INC.
18109 NE 76TH STREET 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
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