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510(k) K070430

PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS by Unomedical A/S — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2007
Date Received
February 13, 2007
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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