De Novo DEN080011

Device
SNAP WOUND CARE DEVICE
Contact
janice m hogan
De Novo number
DEN080011
Product code
OKO
Regulation
878.4683
Classification name
negative pressure wound therapy non-powered suction apparatus
Decision
granted (DENG)
Decision date
2009-08-07
Date received
2008-11-03
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
OKO
Device name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4683
Implant
N
Life sustain/support
N