HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03

Pump, Infusion, Pca

HOSPIRA, INC.

The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03.

Pre-market Notification Details

Device IDK043256
510k NumberK043256
Device Name:HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
ClassificationPump, Infusion, Pca
Applicant HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest,  IL  60045 -5045
ContactPatricia Melerski
CorrespondentPatricia Melerski
HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest,  IL  60045 -5045
Product CodeMEA  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-24
Decision Date2004-12-06
Summary:summary

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