The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius F8 Dialyzer.
| Device ID | K883195 |
| 510k Number | K883195 |
| Device Name: | FRESENIUS F8 DIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Thomas E Cane |
| Correspondent | Thomas E Cane FRESENIUS USA, 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 | 1988-07-28 |
| Decision Date | 1988-09-13 |