The following data is part of a premarket notification filed by Sartorius Filters, Inc. with the FDA for Hemo-processing System.
| Device ID | K830487 |
| 510k Number | K830487 |
| Device Name: | HEMO-PROCESSING SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | SARTORIUS FILTERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-04-28 |