LifeCare PCA Infusion System

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.

Pre-market Notification Details

Device IDK143612
510k NumberK143612
Device Name:LifeCare PCA Infusion System
ClassificationPump, Infusion, Pca
Applicant Hospira, Inc 275 North Field Drive Lake Forest,  IL  60045
ContactTom Gutierrez
CorrespondentYuliya Matlin
Hospira, Inc 275 North Field Drive Lake Forest,  IL  60045
Product CodeMEA  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-19
Decision Date2016-04-08
Summary:summary

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