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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 St.
New Industrial Zone
Yokneam,  IL 20692
Applicant Contact SHOSH FRIEDMAN
Correspondent
Given Imaging , Ltd.
13 Hayetzira St.
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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