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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, Pca
510(k) Number K042800
Device Name LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
Applicant
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
D-389
LAKE FOREST,  IL  60045 -5045
Applicant Contact THOMAS KOZMA
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number880.5725
Classification Product Code
MEA  
Date Received10/08/2004
Decision Date 10/18/2004
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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