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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 K052052
Device Name HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
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
FRN  
Date Received07/29/2005
Decision Date 08/24/2005
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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