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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 external airway
De Novo Number DEN140024
Device Name cNEP Airway
16885 via del campo, suite 135
san diego,  CA  92127
Contact richard rose
Regulation Number868.5105
Classification Product Code
Date Received08/18/2014
Decision Date 12/23/2015
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct