510(k) DEN210034
- Device
- ONE Male Condom
- Applicant
- Global Protection Corp.
- 510(k) number
- DEN210034
- Product code
- QRZ
- Decision
- Unknown (DENG)
- Decision date
- 2022-02-23
- Date received
- 2021-08-26
- Regulation
- 884.5305
- Classification name
- External Condom For Anal Intercourse Or Vaginal Intercourse
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Davin Wedel
- Address
- 12 Channel St. Boston MA US 02210 02210
FDA Registration Numbers#
- 1222115
Source Documents#
510(k) summary PDF not indicated by FDA