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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 K252079
Device Name Disposable Infusion Bag for Parenteral Nutrition
Applicant
Beijing L&Z Medical Technology Development Co., Ltd.
#8, M2-5 Block, Xinggu Industrial Developing Zone,
Pinggu District
Beijing,  CN 101200
Applicant Contact Li Zhiling
Correspondent
Beijing L&Z Medical Technology Development Co., Ltd.
#8, M2-5 Block, Xinggu Industrial Developing Zone,
Pinggu District
Beijing,  CN 101200
Correspondent Contact Li Zhiling
Regulation Number880.5025
Classification Product Code
KPE  
Date Received07/02/2025
Decision Date 04/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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