510(k) K052432

MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 by Medtronic Minimed — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2005
Date Received
September 6, 2005
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