Blood Transfusion Microfilters

Microfilter, Blood Transfusion

Fenwal Inc

The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Blood Transfusion Microfilters.

Pre-market Notification Details

Device IDBK940040
510k NumberBK940040
Device Name:Blood Transfusion Microfilters
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 Received1994-06-23
Decision Date1995-02-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10811137010438 BK940040 0

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