FDA.reportPublic FDA data

De Novo DEN210034

Device
ONE Male Condom
Contact
davin wedel
De Novo number
DEN210034
Product code
QRZ
Regulation
884.5305
Classification name
external condom for anal intercourse or vaginal intercourse
Decision
granted (DENG)
Decision date
2022-02-23
Date received
2021-08-26
Classification advisory
Obstetrics/Gynecology
Review advisory
Obstetrics/Gynecology
Type
Direct

Current FDA Classification#

Product code
QRZ
Device name
External Condom For Anal Intercourse Or Vaginal Intercourse
Medical specialty
Obstetrics/Gynecology
Device class
2
Regulation
884.5305
Implant
N
Life sustain/support
N