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 |