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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 K041191
Device Name COLLEAGUE VOLUMETRIC INFUSION PUMPS
Applicant
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact JENNIFER M PAINE
Correspondent
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact JENNIFER M PAINE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/06/2004
Decision Date 06/25/2004
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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