De Novo DEN120022

Device
X-RAY ATTENUATING CREAM
Contact
rai chowdhary
De Novo number
DEN120022
Product code
PDK
Regulation
892.6510
Classification name
cream for x-ray attenuation
Decision
granted (DENG)
Decision date
2013-05-09
Date received
2012-11-07
Classification advisory
Radiology
Review advisory
Radiology
Type
Direct

Current FDA Classification#

Product code
PDK
Device name
Cream For X-Ray Attenuation
Medical specialty
Radiology
Device class
2
Regulation
892.6510
Implant
N
Life sustain/support
N