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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 K041550
Device Name HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
Applicant
Abbott Laboratories
D-389, Bldg. J45-2
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6157
Applicant Contact PATRICIA MELERSKI
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/09/2004
Decision Date 06/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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