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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 K210015
Device Name Surgical Face Mask
Applicant
Sample King Manufacturing Ltd
Southwest side of the intersection of Mingzhu Boulevard and
Shenyan Road, Yantian District
Shenzhen,  CN 518083
Applicant Contact Forest Cao
Correspondent
Sample King Manufacturing Ltd
Southwest side of the intersection of Mingzhu Boulevard and
Shenyan Road, Yantian District
Shenzhen,  CN 518083
Correspondent Contact Forest Cao
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/04/2021
Decision Date 06/10/2021
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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