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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 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact NICOHL R WILDING
Correspondent
Hospira, Inc.
275 N. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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