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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 K101200
Device Name PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
Applicant
Given Imaging , Ltd.
Shaar Yokneam (Hermon Bldg.
New Industrial Zone,
Yokneam (P.O.Box 258),  IL 20692
Applicant Contact Tim Thomas
Correspondent
Given Imaging , Ltd.
Shaar Yokneam (Hermon Bldg.
New Industrial Zone,
Yokneam (P.O.Box 258),  IL 20692
Correspondent Contact Tim Thomas
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received04/29/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT01088646
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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