NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM— 510(k) K002393

Name: FDA 510(k) clearance K002393
Creator: U.S. Food and Drug Administration
Published: 2000-12-19

Substantially Equivalent

Innolatex Sdn. Bhd

FDA 510(k) clearance K002393 for NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM, Substantially Equivalent on 2000-12-19. 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: 2000-08-07
Decision date: 2000-12-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shah Alam,Selangor Darul Ehsan, 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.