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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 K101677
Device Name HOSPIRA INFUSION BLOOD SETS
Applicant
HOSPIRA, INC.
375 N FIELD DRIVE
LAKE FOREST,  IL  60045
Applicant Contact KAREN KEENER
Correspondent
HOSPIRA, INC.
375 N FIELD DRIVE
LAKE FOREST,  IL  60045
Correspondent Contact KAREN KEENER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/15/2010
Decision Date 08/11/2010
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
Recalls CDRH Recalls
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