Hospira Extension Set

Set, Administration, Intravascular

Hospira, Inc.

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

Pre-market Notification Details

Device IDK142433
510k NumberK142433
Device Name:Hospira Extension Set
ClassificationSet, Administration, Intravascular
Applicant Hospira, Inc. 375 Field Drive Lake Forest,  IL  60045
ContactDavid Blonski
CorrespondentDavid Blonski
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 Received2014-08-29
Decision Date2014-12-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887709102016 K142433 000

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