LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

Pump, Infusion, Pca

HOSPIRA, INC.

The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Lifecare Pca Infusion System With Hospira Mednet Software.

Pre-market Notification Details

Device IDK042800
510k NumberK042800
Device Name:LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
ClassificationPump, Infusion, Pca
Applicant HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest,  IL  60045 -5045
ContactThomas Kozma
CorrespondentNeil E Devine
ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids,  MI  49548
Product CodeMEA  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-10-08
Decision Date2004-10-18
Summary:summary

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