Blood Transfusion Microfilters

Microfilter, Blood Transfusion

Medsep Corporation

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

Pre-market Notification Details

Device IDBK910019
510k NumberBK910019
Device Name:Blood Transfusion Microfilters
ClassificationMicrofilter, Blood Transfusion
Applicant Medsep Corporation 2200 Northern Boulevard East Hills,  NY  11548
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-08
Decision Date1992-01-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887691313940 BK910019 0
30887691305796 BK910019 0
30887691305307 BK910019 0
30887691304218 BK910019 0
30887691000752 BK910019 0
30887691000707 BK910019 0
30887691000431 BK910019 0

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