FDA.reportPublic FDA data

De Novo DEN150010

Device
Dignitana AB DigniCap System
Contact
jan richardsson
De Novo number
DEN150010
Product code
PMC
Regulation
878.4360
Classification name
scalp cooling system
Decision
granted (DENG)
Decision date
2015-12-08
Date received
2015-03-06
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
PMC
Device name
Scalp Cooling System
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4360
Implant
N
Life sustain/support
N