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510(k) K182819

Decanting Device by Gcmedica Enterprise Ltd.(Wuxi) — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2019
Date Received
October 4, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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