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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 K103025
Device Name GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
Applicant
Given Imaging , Ltd.
P.O. Box 258
New Industrial Park
Yoqneam,  IL 20692
Applicant Contact Tim Thomas
Correspondent
Given Imaging , Ltd.
P.O. Box 258
New Industrial Park
Yoqneam,  IL 20692
Correspondent Contact Tim Thomas
Regulation Number876.1300
Classification Product Code
NEZ  
Subsequent Product Code
NSI  
Date Received10/12/2010
Decision Date 05/13/2011
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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