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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, infusion
510(k) Number K063696
Device Name COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
Original Applicant
one baxter parkway
deerfield,  IL  60015 4633
Original Contact jeme wallace
Regulation Number880.5725
Classification Product Code
Date Received12/13/2006
Decision Date 02/27/2007
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls