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FDA 510(k) Application Details - K201483
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K201483
Device Name
Material, Impression
Applicant
Zhengzhou Huaer Electro Optics Technology Co., Ltd
Floor 1, B of Building 18, National University Science Park
of Henan Province
Zhengzhou 450000 CN
Other 510(k) Applications for this Company
Contact
Li XiaoJun
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2020
Decision Date
10/08/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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