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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 K071651
Device Name EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
Applicant
Endogastric Solutions, Inc.
8210 154th Ave. NE
Redmond,  WA  98052
Applicant Contact MICHAEL A DANIEL
Correspondent
Endogastric Solutions, Inc.
8210 154th Ave. NE
Redmond,  WA  98052
Correspondent Contact MICHAEL A DANIEL
Regulation Number876.1500
Classification Product Code
ODE  
Date Received06/18/2007
Decision Date 09/14/2007
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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