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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Esophageal, Wireless, Capsule
510(k) Number K071153
Device Name GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
Applicant
Given Imaging , Ltd.
91 Rockyspring Circle NW
Calgary, Alberta,  CA T3G 6A1
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Given Imaging , Ltd.
91 Rockyspring Circle NW
Calgary, Alberta,  CA T3G 6A1
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number876.1300
Classification Product Code
NSI  
Date Received04/25/2007
Decision Date 06/11/2007
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
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