MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)— 510(k) K070830

Name: FDA 510(k) clearance K070830
Creator: U.S. Food and Drug Administration
Published: 2007-05-08

Substantially Equivalent

Karex Industries Sdn. Bhd.

FDA 510(k) clearance K070830 for MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING), Substantially Equivalent on 2007-05-08. 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: 2007-03-26
Decision date: 2007-05-08
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.