FDA 510(k) Application Details - K020485

Device Classification Name Container, I.V.

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510(K) Number K020485
Device Name Container, I.V.
Applicant BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE, IL 60073 US
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Contact MARY KONKOWSKI
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Regulation Number 880.5025

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Classification Product Code KPE
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Date Received 02/13/2002
Decision Date 03/12/2002
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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