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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 K212460
Device Name Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
Applicant
Guangzhou ZhengKang Medical Equipment Co.,Ltd
Room101,No.9Nanling Zhongxin Kuang Road,Taihe Town
Baiyun District
GuangZhou,  CN 510540
Applicant Contact Mike Wu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90
Qianhai Road
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/05/2021
Decision Date 11/05/2021
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
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