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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K223467
Device Name Disposable Isolation Gown
Applicant
Nanning Tecbod Biological Technology Co., Ltd.
Rm. 601 Fool 6, B2 Bldg., # 19 Guokai Dadao,
Naning,  CN 530033
Applicant Contact Bing Yao Chen
Correspondent
Shanghai Sungo Management Consulting Company , Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number878.4040
Classification Product Code
FYC  
Date Received11/17/2022
Decision Date 02/10/2023
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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