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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K212994
Device Name Medical Face Mask
Applicant
Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.
Bldg. B27 Huachuang Animation Industrial Park,
Jinshan Village, Shiqi Town, Panyu District
Guangzhou,  CN 511450
Applicant Contact Hao Zheng
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/20/2021
Decision Date 01/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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