SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

Microfilter, Blood Transfusion

SUMMIT MEDICAL LTD.

The following data is part of a premarket notification filed by Summit Medical Ltd. with the FDA for Summit Medical Ltd Transfusion Filter, Model Lf400 & Summit Medical Ltd Transfusion Filter With Administration Set.

Pre-market Notification Details

Device IDK022477
510k NumberK022477
Device Name:SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
ClassificationMicrofilter, Blood Transfusion
Applicant SUMMIT MEDICAL LTD. BUSINESS & TECHNOLOGY CENTRE BESSEMER DRIVE Stevenage Hertfordshire,  GB Sgi 2dx
ContactNeil R Armstrong
CorrespondentNeil R Armstrong
SUMMIT MEDICAL LTD. BUSINESS & TECHNOLOGY CENTRE BESSEMER DRIVE Stevenage Hertfordshire,  GB Sgi 2dx
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-29
Decision Date2002-10-25
Summary:summary

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