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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 K202650
Device Name Medical disposable face mask non sterile
Applicant
Guangdong Zhong Ling Industrial Group Co., Ltd.
Rm. 101, Bldg. 1, # 5, Shengfeng Rd.
Xinhe Wanjiang, Dongguan,  CN 523045
Applicant Contact Ann Ho
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 215, Huaming Bldg., Chebei Rd.
Guangzhou,  CN 511660
Correspondent Contact Jinghua Zhou
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/14/2020
Decision Date 03/24/2021
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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