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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K062875
Device Name ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
Applicant
Endogastric Solutions, Inc.
8210 154th Ave. NE
Redmond,  WA  98052
Applicant Contact STEVEN J HOFFMAN
Correspondent
Endogastric Solutions, Inc.
8210 154th Ave. NE
Redmond,  WA  98052
Correspondent Contact STEVEN J HOFFMAN
Regulation Number876.1500
Classification Product Code
OCW  
Date Received09/26/2006
Decision Date 03/09/2007
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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