NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM— 510(k) K023128

Name: FDA 510(k) clearance K023128
Creator: U.S. Food and Drug Administration
Published: 2003-01-22

Substantially Equivalent

Secure Scientific Sdn Bhd

FDA 510(k) clearance K023128 for NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM, Substantially Equivalent on 2003-01-22. Applicant: Secure Scientific Sdn Bhd. Device class: 2.

Clearance details

Applicant: Secure Scientific Sdn Bhd
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2002-09-19
Decision date: 2003-01-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lunas, Kedah, 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.