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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 K041738
Device Name BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)
Applicant
BAXTER HEALTHCARE CORPORATION
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073 -0490
Applicant Contact KAREN SPRANGER
Correspondent
BAXTER HEALTHCARE CORPORATION
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073 -0490
Correspondent Contact KAREN SPRANGER
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
MEB  
Date Received06/28/2004
Decision Date 07/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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