Device Classification Name |
external condom for anal intercourse or vaginal intercourse
|
De Novo Number |
DEN210034 |
Device Name |
ONE Male Condom |
Requester |
Global Protection Corp. |
12 channel street |
boston,
MA
02210
|
|
Contact |
davin wedel |
|
Regulation Number | 884.5305
|
Classification Product Code |
|
Date Received | 08/26/2021 |
Decision Date | 02/23/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|