Device Classification Name |
intraoral cooling device
|
De Novo Number |
DEN210027 |
Device Name |
The Cooral System |
Requester |
BrainCool AB |
scheelevägen 2, medicon village |
lund,
SE
223 81
|
|
Contact |
martin waleij |
|
Regulation Number | 872.5590
|
Classification Product Code |
|
Date Received | 07/02/2021 |
Decision Date | 10/14/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Dental
|
Review Advisory Committee |
Dental
|
Reclassification Order |
Reclassification Order
|
Type |
Direct
|
|
|