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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 K214088
Device Name Disposable Surgical Gown
Applicant
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
No.567, Gushan Road, Area of Economy and Technique
Weihai,  CN 264207
Applicant Contact Bin Dong
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912 Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received12/28/2021
Decision Date 04/12/2022
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
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