NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS— 510(k) K062730

Name: FDA 510(k) clearance K062730
Creator: U.S. Food and Drug Administration
Published: 2006-10-05

Substantially Equivalent

Biogreen Medical Sdn. Bhd.

FDA 510(k) clearance K062730 for NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS, Substantially Equivalent on 2006-10-05. Applicant: Biogreen Medical Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Biogreen Medical Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2006-09-13
Decision date: 2006-10-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ipoh, Perak, 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.