ONE Male Condom— 510(k) DEN210034

Unknown

Global Protection Corp.

FDA 510(k) clearance DEN210034 for ONE Male Condom, Unknown on 2022-02-23. Applicant: Global Protection Corp.. Device class: 2.

Clearance details

Applicant: Global Protection Corp.
Product code: Code QRZ
Device class: Class 2
Regulation: 21 CFR 884.5305
Advisory panel: Obstetrics/Gynecology
Date received: 2021-08-26
Decision date: 2022-02-23
Decision: Unknown
Clearance type: Direct
Location: Boston, MA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.