FDA.reportPublic FDA data

De Novo DEN090005

Device
PRINEO SKIN CLOSURE SYSTEM
Contact
bruce krattenmaker
De Novo number
DEN090005
Product code
OMD
Regulation
878.4011
Classification name
cutaneous tissue adhesive with mesh
Decision
granted (DENG)
Decision date
2010-04-30
Date received
2009-03-24
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
OMD
Device name
Cutaneous Tissue Adhesive With Mesh
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4011
Implant
N
Life sustain/support
N