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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K222622
Device Name Disposable Infusion Bag for Parenteral Nutrition
Applicant
Beijing L&Z Medical Technology Development Co., Ltd.
N0.8, M2-5 Block, Xinggu Industrial Developing Zone,
Pinggu District
Beijing,  CN 101200
Applicant Contact QiuHong Dong
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5025
Classification Product Code
KPE  
Date Received08/31/2022
Decision Date 02/16/2023
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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