FDA 510(k) Application Details - K041738

Device Classification Name Pump, Infusion

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510(K) Number K041738
Device Name Pump, Infusion
Applicant BAXTER HEALTHCARE CORPORATION
ROUTE 120 AND WILSON RD.
ROUND LAKE, IL 60073-0490 US
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Contact KAREN SPRANGER
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 06/28/2004
Decision Date 07/09/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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