Hospira Extension Sets

Set, Administration, Intravascular

Hospira, Inc.

The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Extension Sets.

Pre-market Notification Details

Device IDK151969
510k NumberK151969
Device Name:Hospira Extension Sets
ClassificationSet, Administration, Intravascular
Applicant Hospira, Inc. 375 Field Drive Lake Forest,  IL  60045
ContactCharles Neitzel
CorrespondentCharles Neitzel
Hospira, Inc. 375 Field Drive Lake Forest,  IL  60045
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-16
Decision Date2016-01-19
Summary:summary

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