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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 eating disorder conditioning tool
De Novo Number DEN070014
510(K) Number K063817
Device Name MANDOMETER III
Requester
ab mando
16787 bernardo center dr.,
suite a-1
san diego,  CA  92128
Contact kim bloom
Regulation Number882.5060
Classification Product Code
OBV  
Date Received06/20/2007
Decision Date 03/31/2011
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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