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510(k) K132734

NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS by Baxter Healthcare Corp — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2013
Date Received
September 3, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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