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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pediatric/child facemask
510(k) Number K201514
Device Name Child Face Mask
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.
Room 703, 705, Baohua International Plaza,
West Guangzhong Road 555, Jingan
Shanghai,  CN 200071
Correspondent Contact Shelley Li
Regulation Number878.4040
Classification Product Code
OXZ  
Date Received06/08/2020
Decision Date 10/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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