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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, Bldg. 2, No 889 N. Huancheng Rd.,
Fu'Xi Subdistrict, Deqing County
Huzhou,  CN 313200
Applicant Contact Eric Jian
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 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
Predetermined Change
Control Plan Authorized		 No
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