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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 K202676
Device Name Disposable Medical Face Mask
Applicant
Zhejiang Senhong Medical&Instrument Co., Ltd.
Floor 1-2, Building 2, No 889 North Huancheng Rd,
Fu'xi Subdistrict, Deqing County
Huzhou,  CN 313200
Applicant Contact Eric Jian
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.608, No.738, Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/15/2020
Decision Date 11/05/2021
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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