FDA 510(k) Application Details - K002679

Device Classification Name Pump, Infusion

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510(K) Number K002679
Device Name Pump, Infusion
Applicant BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE, IL 60073 US
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Contact JENNIFER M PAINE
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 08/28/2000
Decision Date 09/18/2000
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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