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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
Original Applicant
HOSPIRA, INC.
375 n field drive
lake forest,  IL  60045
Original 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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