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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 K222204
Device Name Medical Surgical Mask
Applicant
Guangzhou Zhengkang Medical Equipment Co.,Ltd
Rm.101, #9 Nanling Zhongxin Kuang Rd., Taihe Town
Baiyun District
Guangzhou,  CN 510540
Applicant Contact Mike Wu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Center, # 3101-90
Qianhai Rd., Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Riley Chen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/25/2022
Decision Date 09/23/2022
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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