Device Classification Name |
scalp cooling system
|
De Novo Number |
DEN150010 |
Device Name |
Dignitana AB DigniCap System |
Requester |
dignitana ab |
traktorgranden 3 |
lund,
SE
se-226 60
|
|
Contact |
jan richardsson |
|
Regulation Number | 878.4360
|
Classification Product Code |
|
Date Received | 03/06/2015 |
Decision Date | 12/08/2015 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|