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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 K201380
Device Name Livocare Surgical Mask
Applicant
Andon Health Co., Ltd.
No. 3 Jin Ping Street,Ya An Road, Nankai District
Tianjin,  CN 300190
Applicant Contact Liu Yi
Correspondent
Andon Health Co., Ltd.
No. 3 Jin Ping Street,Ya An Road, Nankai District
Tianjin,  CN 300190
Correspondent Contact Liu Yi
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/26/2020
Decision Date 10/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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