The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius As 104 Cell Separator.
| Device ID | K895435 |
| 510k Number | K895435 |
| Device Name: | FRESENIUS AS 104 CELL SEPARATOR |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Garry J Vibert |
| Correspondent | Garry J Vibert FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| 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 | 1989-09-07 |
| Decision Date | 1990-11-02 |