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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion
510(k) Number K070398
Device Name HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Applicant Contact NICOHL R WILDING
Correspondent
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Correspondent Contact NICOHL R WILDING
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/12/2007
Decision Date 04/24/2007
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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