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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 K213177
Device Name Plus Medical Cover Gown
Applicant
Foshan Nanhai Plus Medical CO LTD
Shatou Jiujiang Town, Nanhai District, Foshan,
Foshan,  CN 528200
Applicant Contact Eric Li
Correspondent
Guangzhou Osmunda Medical Device Technical Services Co.,Ltd.
8-9th Floor, R&D Building, No.26 Qinglan Street,
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/28/2021
Decision Date 05/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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