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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 system, imaging, gastrointestinal, wireless, capsule
De Novo Number DEN010002
510(K) Number K010312
Device Name GIVEN DIAGNOSTIC IMAGING SYSTEM
Requester
given imaging , ltd.
117 ahuzah st.
ra'ananna 43373,  IL 43373
Contact shoshana friedman
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received06/11/2001
Decision Date 08/01/2001
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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