FDA 510(k) Application Details - K052828

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K052828
Device Name Transducer, Blood-Pressure, Extravascular
Applicant HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST, IL 60045 US
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Contact THOMAS KOZMA
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 10/05/2005
Decision Date 02/17/2006
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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