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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 infrared hematoma detector
De Novo Number DEN100002
510(K) Number K080377
Device Name INFRASCANNER, MODEL 1000
Requester
INFRASCAN, INC.
3508 market st., suite 215
philadelphia,  PA  19104 -3320
Contact steven b datlof
Regulation Number882.1935
Classification Product Code
OPT  
Date Received04/08/2010
Decision Date 12/13/2011
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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