De Novo DEN150007

Device
Magnetic Surgical System
Contact
cindy domecus
De Novo number
DEN150007
Product code
PNL
Regulation
878.4815
Classification name
magnetic surgical system
Decision
granted (DENG)
Decision date
2016-06-13
Date received
2015-02-10
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
PNL
Device name
Magnetic Surgical System
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4815
Implant
N
Life sustain/support
N