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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 N. Field Dr.
Bldg. 2
Lake Forest,  IL  60045 -5045
Applicant Contact KAREN KEENER
Correspondent
Hospira, Inc.
375 N. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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