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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 K210222
Device Name Disposable Medical Mask
Applicant
Guangdong Lide Medical Technology Co., Ltd.
Hfdb-05-2102 Ecological Technology City, W. Side Of Haizi
Rd.
Shanwei,  CN
Applicant Contact Zhuang Shenglin
Correspondent
Microkn Business Consulting (Shanghai) Co., Ltd.
Rm. 1215, Block A, No 3699, Gonghexin Rd., Jingan District
Shanghai,  CN 200435
Correspondent Contact Yuling Chen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/28/2021
Decision Date 11/02/2021
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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