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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 K092400
Device Name ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
Applicant
Endogastric Solutions, Inc.
8210 154th Ave. NE
Redmond,  WA  98052
Applicant Contact STEVE HOFFMAN
Correspondent
Endogastric Solutions, Inc.
8210 154th Ave. NE
Redmond,  WA  98052
Correspondent Contact STEVE HOFFMAN
Regulation Number876.1500
Classification Product Code
ODE  
Date Received08/06/2009
Decision Date 11/06/2009
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
Recalls CDRH Recalls
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