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FDA 510(k)

CL-DC20, CL-DC21

K-Number: K093751 · 2010-02-24

ApplicantGood Doctors Co., Ltd.
Decision Date2010-02-24
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CL-DC20, CL-DC21 is the device name listed in this FDA 510(k) record. The listed applicant is Good Doctors Co., Ltd.. It received FDA 510(k) clearance on 2010-02-24 under 510(k) number K093751. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CL-DC20, CL-DC21?

CL-DC20, CL-DC21 is a medical device that received FDA 510(k) clearance on 2010-02-24. The listed applicant is Good Doctors Co., Ltd.. The 510(k) number is K093751.

When did CL-DC20, CL-DC21 receive FDA 510(k) clearance?

CL-DC20, CL-DC21 received FDA 510(k) clearance on 2010-02-24, under 510(k) number K093751.

Who is the listed applicant for CL-DC20, CL-DC21?

The FDA 510(k) record lists Good Doctors Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CL-DC20, CL-DC21?

The FDA product code for CL-DC20, CL-DC21 is EBZ.

Other records listing Good Doctors 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.

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Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

Official Source

View on FDA Database →

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

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