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.
Device ID | K111702 |
510k Number | K111702 |
Device Name: | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE |
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 | No |
Date Received | 2011-06-17 |
Decision Date | 2012-03-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04086000100168 | K111702 | 000 |
04086000100151 | K111702 | 000 |