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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 K210030
Device Name Medical Surgical Mask
Applicant
Tianjin Aoshang Outdoor Equipment Co., Ltd.
C-1-106, #23 Xiangtan Rd., Hongqiao District, Tianjin
Tianjin,  CN 300133
Applicant Contact Xiaoning Zhang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/05/2021
Decision Date 04/23/2021
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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