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510(k) K252079

Disposable Infusion Bag for Parenteral Nutrition by Beijing L&Z Medical Technology Development Co., Ltd. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2026
Date Received
July 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

Other clearances by Beijing L&Z Medical Technology Development Co., Ltd.

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  • K223674 — eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (September 1, 2023)
  • K222622 — Disposable Infusion Bag for Parenteral Nutrition (February 16, 2023)
  • K210749 — Empty EVA Bag (August 19, 2021)
  • K201936 — SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (May 6, 2021)
  • K193528 — Empty EVA Bag (July 22, 2020)