The following data is part of a premarket notification filed by Fresenius Kabi Usa Llc with the FDA for Amicus Separator System, Amicus Separator System; Refurbished.
| Device ID | K162462 |
| 510k Number | K162462 |
| Device Name: | AMICUS Separator System, AMICUS Separator System; Refurbished |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | FRESENIUS KABI USA LLC THREE CORPORATE DRIVE Lake Zurich, IL 60047 |
| Contact | Kim Forch |
| Correspondent | Kim Forch FRESENIUS KABI USA LLC THREE CORPORATE DRIVE Lake Zurich, IL 60047 |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-02 |
| Decision Date | 2016-11-23 |
| Summary: | summary |