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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
Recalls CDRH Recalls
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