FDA 510(k) Application Details - K063239

Device Classification Name Tubing, Fluid Delivery

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510(K) Number K063239
Device Name Tubing, Fluid Delivery
Applicant HOSPIRA, INC.
275 NORTH FIELD DR.
DEPT. 389, BLDG. H2
LAKE FOREST, IL 60045 US
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Contact DIANE RENNPFERD
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Regulation Number 880.5440

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Classification Product Code FPK
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Date Received 10/26/2006
Decision Date 12/11/2006
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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