LARGE/EXTRA LAGRE CONDOM— 510(k) K113061

Name: FDA 510(k) clearance K113061
Creator: U.S. Food and Drug Administration
Published: 2011-12-07

Substantially Equivalent

Karex Industries Sdn. Bhd.

FDA 510(k) clearance K113061 for LARGE/EXTRA LAGRE CONDOM, Substantially Equivalent on 2011-12-07. Applicant: Karex Industries Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Karex Industries Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2011-10-14
Decision date: 2011-12-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Johor Darul Takzim, MY

Download summary PDF View on FDA.gov ↗

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