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FDA 510(k)

M. DIOR BRAND

K-Number: K083817 · 2009-09-16

Decision Date2009-09-16
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

M. DIOR BRAND is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Colour-Way Enterprise Development Co., Ltd.. It received FDA 510(k) clearance on 2009-09-16 under 510(k) number K083817. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M. DIOR BRAND?

M. DIOR BRAND is a medical device that received FDA 510(k) clearance on 2009-09-16. The listed applicant is Suzhou Colour-Way Enterprise Development Co., Ltd.. The 510(k) number is K083817.

When did M. DIOR BRAND receive FDA 510(k) clearance?

M. DIOR BRAND received FDA 510(k) clearance on 2009-09-16, under 510(k) number K083817.

Who is the listed applicant for M. DIOR BRAND?

The FDA 510(k) record lists Suzhou Colour-Way Enterprise Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M. DIOR BRAND?

The FDA product code for M. DIOR BRAND is HIS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Suzhou Colour-Way Enterprise Development Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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