FDA.reportPublic FDA data

510(k) K222622

Device
Disposable Infusion Bag for Parenteral Nutrition
Applicant
Beijing L&Z Medical Technology Development Co., Ltd.
510(k) number
K222622
Product code
KPE
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-16
Date received
2022-08-31
Regulation
880.5025
Classification name
Container, I.V.
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
QiuHong Dong
Address
N0.8, M2-5 Block, Xinggu Industrial Developing Zone, Pinggu District Beijing CN 101200 101200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.2026-04-02
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K210749Empty EVA BagHaemotronic S.P.A.2021-08-19
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K190328HCT Empty EVA Container PackHealth Care Technologies2019-08-15
K190305Additive CapInternational Medical Industries, Inc.2019-04-30
K181393Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BPValmed S.R.L.2019-02-15
K132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 MLHospira, Inc.2013-11-12
K121161EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINERActa Medical, LLC2012-07-13