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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 K212718
Device Name Surgical gowns
Applicant
Xiantao Dingcheng Non-Woven Product Co., Ltd
Liukou Industrial Park
Xiantao,  CN 433099
Applicant Contact Cheng Qin
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Room 608, No.738, Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/27/2021
Decision Date 01/12/2022
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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