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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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