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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 (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls