FDA.reportPublic FDA data

De Novo DEN060003

Device
TEPHAFLEX ABSORBABLE SUTURE
Contact
mary p legraw
De Novo number
DEN060003
Product code
NWJ
Regulation
878.4494
Classification name
suture, recombinant technology
Decision
granted (DENG)
Decision date
2007-02-08
Date received
2006-05-12
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
NWJ
Device name
Suture, Recombinant Technology
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4494
Implant
Y
Life sustain/support
N