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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 K221352
Device Name Surgical Face Mask
Applicant
Wuhan Huashida Protective Products Co., Ltd.
#511 Weihu Rd., Shamao St., Hannan District
Wuhan,,  CN 430090
Applicant Contact Chen Mei
Correspondent
Wuhan Huashida Protective Products Co., Ltd.
#511 Weihu Rd., Shamao St., Hannan District
Wuhan,,  CN 430090
Correspondent Contact Chen Mei
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/10/2022
Decision Date 03/13/2023
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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