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510(k) K061128

MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM by Medrad, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2006
Date Received
April 24, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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