The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Fresenius Hemoflow F60 & Fresenius Hemoflow F40.
| Device ID | K852251 |
| 510k Number | K852251 |
| Device Name: | FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Lipps, Ph.d. |
| Correspondent | Lipps, Ph.d. SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-23 |
| Decision Date | 1985-07-25 |