JOE LUB HELMET CONDOM— 510(k) K011378

Name: FDA 510(k) clearance K011378
Creator: U.S. Food and Drug Administration
Published: 2002-03-25

Substantially Equivalent

Marketing Sales Concepts, Inc. (Msci)

FDA 510(k) clearance K011378 for JOE LUB HELMET CONDOM, Substantially Equivalent on 2002-03-25. Applicant: Marketing Sales Concepts, Inc. (Msci). Device class: 2.

Clearance details

Applicant: Marketing Sales Concepts, Inc. (Msci)
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2001-05-03
Decision date: 2002-03-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Atlanta, 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.