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510(k) K100946

INTRAVSCULAR ADMINISTRATION SET by Terumo Europe N.V. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2010
Date Received
April 6, 2010
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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