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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 K220777
Device Name Surgical face mask
Applicant
Hubei Qianjiang Kingphar Medical Material Co., Ltd.
Yuanguang Rd.
Qianjiang,  CN 433100
Applicant Contact Zhao Fusong
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 Received03/17/2022
Decision Date 07/19/2022
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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