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FDA 510(k)

MINI L.E.D. OEM MODULE

K-Number: K040808 · 2004-04-28

ApplicantSatelec
Decision Date2004-04-28
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINI L.E.D. OEM MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 2004-04-28 under 510(k) number K040808. 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 MINI L.E.D. OEM MODULE?

MINI L.E.D. OEM MODULE is a medical device that received FDA 510(k) clearance on 2004-04-28. The listed applicant is Satelec. The 510(k) number is K040808.

When did MINI L.E.D. OEM MODULE receive FDA 510(k) clearance?

MINI L.E.D. OEM MODULE received FDA 510(k) clearance on 2004-04-28, under 510(k) number K040808.

Who is the listed applicant for MINI L.E.D. OEM MODULE?

The FDA 510(k) record lists Satelec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI L.E.D. OEM MODULE?

The FDA product code for MINI L.E.D. OEM MODULE is EBZ.

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.

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Other records listing Satelec 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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