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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 K211509
Device Name Surgical Gown
Applicant
Hubei Wanli Protective Products Co., Ltd.
Tangwan St., Xiliuhe Town
Xiantao,  CN
Applicant Contact Andy Wen
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
FYA  
Date Received05/14/2021
Decision Date 10/24/2021
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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