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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 K103224
Device Name HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
Applicant
HOSPIRA, INC.
375 NORTH FIELD DR.
BLDG. 2
LAKE FOREST,  IL  60045 -5045
Applicant Contact KAREN KEENER
Correspondent
HOSPIRA, INC.
375 NORTH FIELD DR.
BLDG. 2
LAKE FOREST,  IL  60045 -5045
Correspondent Contact KAREN KEENER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/01/2010
Decision Date 01/07/2011
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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