AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED

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/ Amicus Seperator System;refurbished.

Pre-market Notification Details

Device IDK141019
510k NumberK141019
Device Name:AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED
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 ProductYes
Date Received2014-04-21
Decision Date2014-06-10
Summary:summary

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