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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 K210380
Device Name Medical surgical mask
Applicant
Shantou T&K Medical Equipment Factory Co.,Ltd
#8 Workshop, Wanji S. Second St.
Shantou,  CN 515065
Applicant Contact Wan Li
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plaza
West Guangzhong Rd. 555
Shanghai,  CN 200071
Correspondent Contact Stuart Situ
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/09/2021
Decision Date 07/08/2021
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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