Microfilter, Blood Transfusion

Microfilter, Blood Transfusion

Hemasure, Inc.

The following data is part of a premarket notification filed by Hemasure, Inc. with the FDA for Microfilter, Blood Transfusion.

Pre-market Notification Details

Device IDBK980014
510k NumberBK980014
Device Name:Microfilter, Blood Transfusion
ClassificationMicrofilter, Blood Transfusion
Applicant Hemasure, Inc. 140 Locke Drive Marlborough,  MA  01752
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-18
Decision Date1999-05-27

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