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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
Applicant
BAXTERHEALTHCARE, INC.
ONE BAXTER PARKWAY
DEERFIELD,  IL  60015 -4633
Applicant Contact JEME WALLACE
Correspondent
BAXTERHEALTHCARE, INC.
ONE BAXTER PARKWAY
DEERFIELD,  IL  60015 -4633
Correspondent Contact JEME WALLACE
Regulation Number880.5725
Classification Product Code
FRN  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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