AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE

Separator, Automated, Blood Cell And Plasma, Therapeutic

FENWAL, INC.

The following data is part of a premarket notification filed by Fenwal, Inc. with the FDA for Amicus Separator System- Use In Therapeutic Plasma Exchange And Filter Set For Amicus Tpe.

Pre-market Notification Details

Device IDK111702
510k NumberK111702
Device Name:AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant FENWAL, INC. THREE CORPORATE DRIVE Lake Zurich,  IL  60047
ContactKim Forch
CorrespondentKim Forch
FENWAL, INC. THREE CORPORATE DRIVE Lake Zurich,  IL  60047
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-17
Decision Date2012-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04086000100168 K111702 000
04086000100151 K111702 000

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