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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, Gastrointestinal, Wireless, Capsule
510(k) Number K070475
Device Name MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
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
NEZ  
Date Received02/20/2007
Decision Date 05/07/2007
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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