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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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More FDA Info for this Product Code
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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