FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72

Microfilter, Blood Transfusion

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Fenwal 20 Micron Pediatric Transfusion Filter Model 4c7701, Fenwal 20 Micron Pediatric Transfusion Filter Set Model 4c72.

Pre-market Notification Details

Device IDK982822
510k NumberK982822
Device Name:FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
ClassificationMicrofilter, Blood Transfusion
Applicant BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake,  IL  60073
ContactMary Ellen Snyder
CorrespondentMary Ellen Snyder
BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake,  IL  60073
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-11
Decision Date1998-09-30
Summary:summary

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