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 |