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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 K213893
Device Name Comfort Gown, Safewear Gown
Applicant
Xuchang Zhengde Environstar Medical Products Co., Ltd.
Area B, Baihua Rd. E., S. Side Of Erji River, Industry
Cluster District, Yanling County,
Xuchang,  CN 461200
Applicant Contact Vincent Yu
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 Received12/14/2021
Decision Date 12/21/2022
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
Predetermined Change
Control Plan Authorized		 No
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