TheyFit Male Condom— 510(k) K150072

Substantially Equivalent

Theyfit

FDA 510(k) clearance K150072 for TheyFit Male Condom, Substantially Equivalent on 2015-04-14. Applicant: Theyfit. Device class: 2.

Clearance details

Applicant: Theyfit
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2015-01-14
Decision date: 2015-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

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