FDA 510(k) Application Details - K062999

Device Classification Name Catheter, Oximeter, Fiberoptic

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510(K) Number K062999
Device Name Catheter, Oximeter, Fiberoptic
Applicant HOSPIRA, INC.
275 NORTH FIELD DR.
DEPT. 389, BLDG. H2-2
LAKE FOREST, IL 60045 US
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Contact DIANE RENNPFERD
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Regulation Number 870.1230

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Classification Product Code DQE
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Date Received 10/02/2006
Decision Date 11/03/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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