DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT— 510(k) K042957

Name: FDA 510(k) clearance K042957
Creator: U.S. Food and Drug Administration
Published: 2005-02-17

Substantially Equivalent

Ssl Americas

FDA 510(k) clearance K042957 for DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT, Substantially Equivalent on 2005-02-17. Applicant: Ssl Americas. Device class: 2.

Clearance details

Applicant: Ssl Americas
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2004-10-27
Decision date: 2005-02-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Norcross, 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.