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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K201483
Device Name Impression Material
Applicant
Zhengzhou Huaer Electro Optics Technology Co., Ltd.
Floor 1, B Of Bldg. 18, National University Science Park
Of Henan Province
Zhengzhou,  CN 450000
Applicant Contact Li XiaoJun
Correspondent
Shanghai Sungo Management Consulting Company Limited.
13th Floor, 1500# Central Ave.
Shangghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/04/2020
Decision Date 10/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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