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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 K211750
Device Name Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
Applicant
National Bridge Industrial (S.Z.) Co., Ltd.
Phase 2, N.B.I. Building, No. 501-502, Sili Road,
Guanlan, Longhua District,
Shenzhen,  CN 518000
Applicant Contact Yang Haixiong
Correspondent
Shenzhen Joyantech Consulting Co. Ltd
1713A, 17th Floor, Block A, Zhongguan Times Square,
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/07/2021
Decision Date 12/20/2021
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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