The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Fresenius Haemodialysis A2008.
| Device ID | K843014 |
| 510k Number | K843014 |
| Device Name: | FRESENIUS HAEMODIALYSIS A2008 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Ben J Lipps |
| Correspondent | Ben J Lipps 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 | 1984-07-31 |
| Decision Date | 1984-10-18 |