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510(k) K121182

VIALOK NON-VENTED by Yukon Medical, LLC — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2012
Date Received
April 18, 2012
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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