FDA 510(k)

COOL CURE

K-Number: K030811 · 2003-06-10

Decision Date2003-06-10

Product CodeEBZ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

COOL CURE is the device name listed in this FDA 510(k) record. The listed applicant is Samm, Inc.. It received FDA 510(k) clearance on 2003-06-10 under 510(k) number K030811. 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 COOL CURE?

COOL CURE is a medical device that received FDA 510(k) clearance on 2003-06-10. The listed applicant is Samm, Inc.. The 510(k) number is K030811.

When did COOL CURE receive FDA 510(k) clearance?

COOL CURE received FDA 510(k) clearance on 2003-06-10, under 510(k) number K030811.

Who is the listed applicant for COOL CURE?

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

What is the FDA product code for COOL CURE?

The FDA product code for COOL CURE is EBZ.

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) Limited K241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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.