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510(k) K122265

VIALOK SINGLE VIAL ACCESS DEVICE VENTED by Yukon Medical, LLC — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2012
Date Received
July 30, 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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  • K120799 — ARISURE NEUTRAL VALVE (March 30, 2012)

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