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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K222403
Device Name Surgical Gown
Applicant
Guangzhou Fuzelong Hygiene Material Co., Ltd
12, Guancun Road, Jiangpu Street, Conghua
Guangzhou,  CN 510900
Applicant Contact Yuehua Zhou
Correspondent
Shanghai Truthful information Technology Co., Ltd.
RM. 1801, No. 161 Lujiazui East Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/09/2022
Decision Date 01/26/2023
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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