FDA 510(k) Application Details - K132276

Device Classification Name Container, I.V.

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510(K) Number K132276
Device Name Container, I.V.
Applicant HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST, IL 60045 US
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Contact ABIGAIL FERGUSON
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Regulation Number 880.5025

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Classification Product Code KPE
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Date Received 07/22/2013
Decision Date 11/12/2013
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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