LED Curing Light

Activator, Ultraviolet, For Polymerization

EZGO Group Inc.

The following data is part of a premarket notification filed by Ezgo Group Inc. with the FDA for Led Curing Light.

Pre-market Notification Details

Device IDK192009
510k NumberK192009
Device Name:LED Curing Light
ClassificationActivator, Ultraviolet, For Polymerization
Applicant EZGO Group Inc. 8840 Flower Rd 120 Rancho Cucamonga,  CA  91730
ContactHong Chen
CorrespondentJet Li
Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-29
Decision Date2020-01-09

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