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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 K060806
Device Name HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088
Applicant
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
DEPT. 389
LAKE FOREST,  IL  60045
Applicant Contact PATRICIA MELERSKI
Correspondent
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
DEPT. 389
LAKE FOREST,  IL  60045
Correspondent Contact PATRICIA MELERSKI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/24/2006
Decision Date 04/21/2006
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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