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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name colon capsule imaging system
De Novo Number DEN120023
510(K) Number K123666
Device Name GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
Requester
given imaging , ltd.
hermon bldg., new industrial park, p.o. box 258
yoqneam,  IL 20692
Contact tim thomas
Regulation Number876.1330
Classification Product Code
PGD  
Date Received11/29/2012
Decision Date 01/29/2014
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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