FDA 510(k) Application Details - K042800

Device Classification Name Pump, Infusion, Pca

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510(K) Number K042800
Device Name Pump, Infusion, Pca
Applicant HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
D-389
LAKE FOREST, IL 60045-5045 US
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Contact THOMAS KOZMA
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Regulation Number 880.5725

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Classification Product Code MEA
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Date Received 10/08/2004
Decision Date 10/18/2004
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 Y
Expedited Review



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