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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 kit, test, olfactory
De Novo Number DEN050007
510(K) Number K051653
Device Name HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
Requester
fmg innovations, inc.
one financial center
boston,  MA  02111
Contact linda d bentley
Regulation Number874.1600
Classification Product Code
NRK  
Date Received06/20/2005
Decision Date 03/27/2006
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
Type Post-NSE
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