BLACK COLOURED CONDOM— 510(k) K132597

Name: FDA 510(k) clearance K132597
Creator: U.S. Food and Drug Administration
Published: 2013-11-25

Substantially Equivalent

Karex Industries Sdn. Bhd.

FDA 510(k) clearance K132597 for BLACK COLOURED CONDOM, Substantially Equivalent on 2013-11-25. 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: 2013-08-19
Decision date: 2013-11-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Pontian Kecil, Jalan Johor, 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.