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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 K210785
Device Name Disposable Surgical Gowns
Applicant
Chongqing Litai Fashion Group Limited Company
Bldg. D7-1, Chongqing China Textile & Garment City
Project, Maliu Yanjiang Development Zone,
Chongqing,  CN
Applicant Contact David Ni
Correspondent
Shanghai Sungo Management Consulting Company Limited.
Rm. 1309, Dongfang Bldg., 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number878.4040
Classification Product Code
FYC  
Date Received03/16/2021
Decision Date 11/13/2021
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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