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FDA 510(k) Application Details - K222622
Device Classification Name
Container, I.V.
More FDA Info for this Device
510(K) Number
K222622
Device Name
Container, I.V.
Applicant
Beijing L&Z Medical Technology Development Co., Ltd.
N0.8, M2-5 Block, Xinggu Industrial Developing Zone,
Pinggu District
Beijing 101200 CN
Other 510(k) Applications for this Company
Contact
QiuHong Dong
Other 510(k) Applications for this Contact
Regulation Number
880.5025
More FDA Info for this Regulation Number
Classification Product Code
KPE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2022
Decision Date
02/16/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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