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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 K210679
Device Name Medical Face Mask
Applicant
Wuxi Yushou Medical Appliances Co., Ltd.
#115 Nongxinhe Rd., Xishan District, Wuxi City, Jiangsu
Province, China.
Wuxi,  CN 214200
Applicant Contact Xiaoling Dai
Correspondent
Wuxi Yushou Medical Appliances Co., Ltd.
#115 Nongxinhe Rd., Xishan District, Wuxi City, Jiangsu
Province, China.
Wuxi,  CN 214200
Correspondent Contact Xiaoling Dai
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/08/2021
Decision Date 01/18/2022
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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