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Microfilter, Blood Transfusion

Fenwal Inc

The following data is part of a premarket notification filed by Fenwal Inc with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK020008
510k NumberBK020008
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationMicrofilter, Blood Transfusion
Applicant Fenwal Inc three Corporate Drive Lake Zurich,  IL  60047
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-04
Decision Date2002-12-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10811137010483 BK020008 0
14052682004305 BK020008 0

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