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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K103344
Device Name INFUSION SETS
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Applicant Contact REBECCA ANDERSEN
Correspondent
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Correspondent Contact REBECCA ANDERSEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/15/2010
Decision Date 12/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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