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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 K221819
Device Name 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
Applicant
Winner Medical Co., Ltd.
Winner Industrial Park, No.660 Bulong Road, Longhua District
Guangdong,  CN 515109
Applicant Contact Mingni Liu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/23/2022
Decision Date 09/19/2022
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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