LED Curing Light

Activator, Ultraviolet, For Polymerization

Foshan COXO Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Foshan Coxo Medical Instrument Co., Ltd. with the FDA for Led Curing Light.

Pre-market Notification Details

Device IDK220826
510k NumberK220826
Device Name:LED Curing Light
ClassificationActivator, Ultraviolet, For Polymerization
Applicant Foshan COXO Medical Instrument Co., Ltd. BLDG 4, District A, Guangdong New Light Source Industrial Base, South Of Luocun Avenue Nanhai District, Foshan,  CN 528226
ContactYongjian Zheng
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-22
Decision Date2022-12-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06974267890565 K220826 000

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