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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 K201537
Device Name Protective Face Mask for Medical Use
Applicant
Shandong Shengquan New Material Co., Ltd.
Diaozhen Industrial Development Zone,
Zhangqiu District
Jinan,  CN 250204
Applicant Contact Xiumei Zhang
Correspondent
Shanghai Landlink Medical Information Technology Co., Ltd.
Rm. 703, 705, Baohua International Plz.,
West Guangzhong Rd. 555, Jingan
Shanghai,  CN 200071
Correspondent Contact Shelley Li
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/08/2020
Decision Date 09/04/2020
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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