BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR

Set, Blood Transfusion

FENWAL, INC.

The following data is part of a premarket notification filed by Fenwal, Inc. with the FDA for Blood Component Recipient Set With Standard Size Filter And Infusion Set With Side Arm Luer Connector.

Pre-market Notification Details

Device IDK073339
510k NumberK073339
Device Name:BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
ClassificationSet, Blood Transfusion
Applicant FENWAL, INC. THREE CORPORATE DRIVE Lake Zurich,  IL  60047
ContactTammy Davis
CorrespondentTammy Davis
FENWAL, INC. THREE CORPORATE DRIVE Lake Zurich,  IL  60047
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-28
Decision Date2008-03-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10811137010698 K073339 000
10811137010452 K073339 000
10811137010407 K073339 000
14052682004190 K073339 000
14052682004145 K073339 000

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