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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. Bldg., # 501-502, Sili Rd.,
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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