FDA 510(k) Application Details - K110901

Device Classification Name Pump, Infusion

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510(K) Number K110901
Device Name Pump, Infusion
Applicant HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST, IL 60045 US
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Contact Ray Silkaitis
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 03/31/2011
Decision Date 03/05/2012
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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