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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 K203732
Device Name Surgical Face Mask
Applicant
Zhuhai Gaoge Medical Technology Co., Ltd.
3rd Floor, Flat 5, # 6 Jinyuan One St., Tangjiawan Town
Zhuahai National Hi-Tech Industrial Dev
Zhuhai,  CN 519000
Applicant Contact Xiangliang Cheng
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 Received12/21/2020
Decision Date 06/11/2021
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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