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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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