MULTIPLE BRAND MALE LATEX CONDOM— 510(k) K070937

Name: FDA 510(k) clearance K070937
Creator: U.S. Food and Drug Administration
Published: 2007-09-21

Substantially Equivalent

Nulatex Sdn. Bhd.

FDA 510(k) clearance K070937 for MULTIPLE BRAND MALE LATEX CONDOM, Substantially Equivalent on 2007-09-21. Applicant: Nulatex Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Nulatex Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2007-04-04
Decision date: 2007-09-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kluang, 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.