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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K212610
Device Name Surgical Face Mask
Applicant
Foshan Nanhai Plus Medical Co, Ltd.
Shijiang Industrial Zone, Shatou, Jiujiang Town, Nanhai
Foshan,  CN 528208
Applicant Contact Suyi 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
FXX  
Date Received08/17/2021
Decision Date 01/26/2022
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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