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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 intraoral cooling device
De Novo Number DEN210027
Device Name The Cooral System
Requester
braincool ab
scheelevägen 2, medicon village
lund,  SE 22381
Contact martin waleij
Regulation Number872.5590
Classification Product Code
QUA  
Date Received07/02/2021
Decision Date 10/14/2022
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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