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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 K202029
Device Name Medical Surgical Mask
Applicant
Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
#6 Plant W., Valley #1 Bio-Medicine Industry Park
Daxing District
Beijing,  CN 102600
Applicant Contact Ting Jiang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/22/2020
Decision Date 12/16/2020
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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