Automated Blood Cell Separator -Filtration

Separator, Automated, Blood Cell, Diagnostic

Medsep Corporation

The following data is part of a premarket notification filed by Medsep Corporation with the FDA for Automated Blood Cell Separator -filtration.

Pre-market Notification Details

Device IDBK920023
510k NumberBK920023
Device Name:Automated Blood Cell Separator -Filtration
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Medsep Corporation 2200 Northern Boulevard East Hills,  NY  11548
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-19
Decision Date1992-10-26

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