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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 K211809
Device Name Surgical Gown
Applicant
Wuhan Dymex Healthcare Co., Ltd.
Rm. 1701, Unit 2, Bldg. 5, Jinsegangwan Phase 5,
Dongfeng Ave.
Wuhan,  CN 430000
Applicant Contact Lynn Wu
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 Received06/11/2021
Decision Date 10/18/2021
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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