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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 K212812
Device Name Surgical Gown
Applicant
Xianning Marveldas Protective Articles Co., Ltd.
Guishan Rd. #30, Hi-New Industrial
Xianning,  CN
Applicant Contact Zhuxiao Kang
Correspondent
Imd Medical & Drug Technology Service Institutions
Rm. 308, Bldg. 11, # 23, Jinqu Rd., Wanjiang St.
Dongguan,  CN 523069
Correspondent Contact Salon Chen
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/03/2021
Decision Date 11/16/2022
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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