FDA 510(k) Application Details - K133602

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K133602
Device Name Set, I.V. Fluid Transfer
Applicant HOSPIRA, INC.
375 N FIELD DRIVE
LAKE FOREST, IL 60045 US
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Contact KAREN KEENER
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 11/25/2013
Decision Date 01/24/2014
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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