JUD custom fit condom— 510(k) K172414

Name: FDA 510(k) clearance K172414
Creator: U.S. Food and Drug Administration
Published: 2017-10-12

Substantially Equivalent

Global Mailer Partners, LLC

FDA 510(k) clearance K172414 for JUD custom fit condom, Substantially Equivalent on 2017-10-12. Applicant: Global Mailer Partners, LLC. Device class: 2.

Clearance details

Applicant: Global Mailer Partners, LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2017-08-10
Decision date: 2017-10-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Miami Beach, FL, 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.