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510(k) K183187

nextaro Transfer System, nextaro va by Sfm Medical Devices GmbH — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2019
Date Received
November 19, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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