56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM— 510(k) K012964

Name: FDA 510(k) clearance K012964
Creator: U.S. Food and Drug Administration
Published: 2001-11-09

Substantially Equivalent

Innolatex Sdn. Bhd

FDA 510(k) clearance K012964 for 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM, Substantially Equivalent on 2001-11-09. Applicant: Innolatex Sdn. Bhd. Device class: 2.

Clearance details

Applicant: Innolatex Sdn. Bhd
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2001-09-04
Decision date: 2001-11-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shah Alam, Selangor D.E., 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.