FDA 510(k) Application Details - K003730

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K003730
Device Name Set, I.V. Fluid Transfer
Applicant BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE, IL 60073 US
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Contact JUDY KANNENBERG
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 12/04/2000
Decision Date 12/20/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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