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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 K202240
Device Name Disposable Surgical Mask/Fluid Resistant Procedure Mask
Applicant
LHM Medical Technology (Hong Kong) Limited
Unit No. 2, 3/F., Block A, Ko Fai Industrial Building,
7 Ko Fai Road,Yau Tong
hongkong,  CN 999077
Applicant Contact frank cheng
Correspondent
LHM Medical Technology (Hong Kong) Limited
Unit No. 2, 3/F., Block A, Ko Fai Industrial Building,
7 Ko Fai Road,Yau Tong
hongkong,  CN 999077
Correspondent Contact frank cheng
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/10/2020
Decision Date 02/25/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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