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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, blood-pressure, extravascular
510(k) Number K061573
Device Name TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Applicant Contact THOMAS KOZMA
Correspondent
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Correspondent Contact THOMAS KOZMA
Regulation Number870.2850
Classification Product Code
DRS  
Date Received06/07/2006
Decision Date 09/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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