FDA.reportPublic FDA data

De Novo DEN070002

Device
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
Contact
roy carr
De Novo number
DEN070002
Product code
NYS
Regulation
878.4015
Classification name
wound dressing with poly(diallyl dimethyl ammonium chloride)(pdadmac)
Decision
granted (DENG)
Decision date
2009-02-25
Date received
2007-05-10
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
NYS
Device name
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4015
Implant
N
Life sustain/support
N