Impression Material

Material, Impression

Zhengzhou Huaer Electro Optics Technology Co., Ltd

The following data is part of a premarket notification filed by Zhengzhou Huaer Electro Optics Technology Co., Ltd with the FDA for Impression Material.

Pre-market Notification Details

Device IDK201483
510k NumberK201483
Device Name:Impression Material
ClassificationMaterial, Impression
Applicant Zhengzhou Huaer Electro Optics Technology Co., Ltd Floor 1, B Of Building 18, National University Science Park of Henan Province Zhengzhou,  CN 450000
ContactLi Xiaojun
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-04
Decision Date2020-10-08

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