Hospira Blood Set

Set, Administration, Intravascular

HOSPIRA, INC.

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

Pre-market Notification Details

Device IDK143087
510k NumberK143087
Device Name:Hospira Blood Set
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 Received2014-10-27
Decision Date2015-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20887787008832 K143087 000

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