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510(k) K133894

SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) by Terumo Europe N.V. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2014
Date Received
December 20, 2013
Clearance Type
Traditional
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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