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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 K212807
Device Name Surgical Masks
Applicant
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
No. 567 Gushan Road, Area of Economy and Technique
Weihai,  CN 264205
Applicant Contact Bin Dong
Correspondent
Beijing Believe-Med Technology Service Co., Ltd
Rm. 912, Building #15, XiYueHui, No.5, YiHe North RD.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/03/2021
Decision Date 12/03/2021
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
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