FDA.reportPublic FDA data

De Novo DEN040004

Device
CELLERATION MIST THERAPY SYSTEM
Contact
david l bremseth
De Novo number
DEN040004
Product code
NRB
Regulation
878.4410
Classification name
wound cleaner, ultrasound
Decision
granted (DENG)
Decision date
2004-06-25
Date received
2004-04-29
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
NRB
Device name
Wound Cleaner, Ultrasound
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4410
Implant
N
Life sustain/support
N