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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 K202358
Device Name Protective Face Mask for Medical Use
Applicant
Hunan Heng Chang Pharmaceutical Co., Ltd.
Floor 2,3, 102 Of Bldg. 16, Standard Plant Of Shanhe
Pharmaceutical And Health
Changsha,  CN 410000
Applicant Contact Tao Jingfeng
Correspondent
Shanghai Landlink Medical Information Technology Co., Ltd.
Rm. 703, 705, Baohua International Plaza,
West Guangzhong Rd. 555, Jingan
Shanghai,  CN 200071
Correspondent Contact Shelley Li
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/19/2020
Decision Date 01/29/2021
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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