510(k) K222622

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
February 16, 2023
Date Received
August 31, 2022
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