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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K161898
Device Name Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
Applicant
Beijing Fert Technology Co., Ltd.
#9, Zhangguozhuang Village, Changxindian Town
Feng Tai District
Beijing,  CN 100072
Applicant Contact MENG ZHANG
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/11/2016
Decision Date 03/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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