FDA 510(k) Applications Submitted by FENWAL, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K141019 04/21/2014 AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED FENWAL, INC.
K111702 06/17/2011 AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE FENWAL, INC.
K073339 11/28/2007 BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR FENWAL, INC.


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