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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 K042980
Device Name HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
Applicant
Hospira, Inc.
275 N. Field Dr., Bldg. H-2
D-389
Lake Forest,  IL  60045
Applicant Contact PATRICIA MELERSKI
Correspondent
Hospira, Inc.
275 N. Field Dr., Bldg. H-2
D-389
Lake Forest,  IL  60045
Correspondent Contact PATRICIA MELERSKI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/29/2004
Decision Date 11/17/2004
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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