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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
Recalls CDRH Recalls
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