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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K212698
Device Name Plus Medical Isolation Gown Level 3
Applicant
Foshan Nanhai Plus Medical Co, Ltd.
Shatou Jiujiang Town, Nanhai District
Foshan,  CN 528208
Applicant Contact Eric Li
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Bldg., #26 Qinglan St., Panyu
District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number878.4040
Classification Product Code
FYC  
Date Received08/25/2021
Decision Date 03/02/2022
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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