The following data is part of a premarket notification filed by Fenwal, Inc. with the FDA for Amicus Separator System/ Amicus Seperator System;refurbished.
Device ID | K141019 |
510k Number | K141019 |
Device Name: | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED |
Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
Applicant | FENWAL, INC. THREE CORPORATE DRIVE Lake Zurich, IL 60047 |
Contact | Kim Forch |
Correspondent | Kim Forch FENWAL, INC. THREE CORPORATE DRIVE Lake Zurich, IL 60047 |
Product Code | LKN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2014-04-21 |
Decision Date | 2014-06-10 |
Summary: | summary |