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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 media, culture, ex vivo, tissue and cell
De Novo Number DEN000008
510(K) Number K001447
Device Name DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
Requester
life technologies, inc.
555 thirteenth st., nw
washington,  DC  20004 -1109
Contact jonathan s kahan, esq.
Regulation Number876.5885
Classification Product Code
NDS  
Date Received12/19/2000
Decision Date 02/16/2001
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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