MALE LATEX CONDOM— 510(k) K121241

Substantially Equivalent

Nulatex Sdn. Bhd.

FDA 510(k) clearance K121241 for MALE LATEX CONDOM, Substantially Equivalent on 2013-02-14. 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: 2012-04-25
Decision date: 2013-02-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kluang, MY

Download summary PDF View on FDA.gov ↗

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More clearances from Nulatex Sdn. Bhd.

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