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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 K040248
Device Name MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
Applicant
GIVEN IMAGING LTD.
13 HAYETZIRA STREET
NEW INDUSTRIAL ZONE
YOKNEAM,  IL 20692
Applicant Contact SHOSH FRIEDMAN
Correspondent
GIVEN IMAGING LTD.
13 HAYETZIRA STREET
NEW INDUSTRIAL ZONE
YOKNEAM,  IL 20692
Correspondent Contact SHOSH FRIEDMAN
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received02/03/2004
Decision Date 02/17/2004
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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