M. DIOR BRAND— 510(k) K083817

Name: FDA 510(k) clearance K083817
Creator: U.S. Food and Drug Administration
Published: 2009-09-16

Substantially Equivalent

Suzhou Colour-Way Enterprise Development Co., Ltd.

FDA 510(k) clearance K083817 for M. DIOR BRAND, Substantially Equivalent on 2009-09-16. Applicant: Suzhou Colour-Way Enterprise Development Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Colour-Way Enterprise Development Co., Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2008-12-22
Decision date: 2009-09-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Haidian District, Beijing, CN

Download summary PDF View on FDA.gov ↗

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