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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 positive airway pressure system
De Novo Number DEN170089
Device Name Curve Positive Airway Pressure System
FRESCA Medical
1291 puerta del sol, suite 200
san clemente,  CA  92673
Contact mary lou mooney
Regulation Number868.5273
Classification Product Code
Date Received12/14/2017
Decision Date 06/05/2018
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct