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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, Pca
510(k) Number K043256
Device Name HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
Applicant
Hospira, Inc.
275 N. Field Dr., Bldg. H-2
D-389
Lake Forest,  IL  60045 -5045
Applicant Contact PATRICIA MELERSKI
Correspondent
Hospira, Inc.
275 N. Field Dr., Bldg. H-2
D-389
Lake Forest,  IL  60045 -5045
Correspondent Contact PATRICIA MELERSKI
Regulation Number880.5725
Classification Product Code
MEA  
Date Received11/24/2004
Decision Date 12/06/2004
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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