The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Dialyzer Preparation Sys Dps-4.
| Device ID | K832230 |
| 510k Number | K832230 |
| Device Name: | DIALYZER PREPARATION SYS DPS-4 |
| Classification | Dialyzer Reprocessing System |
| Applicant | SERATRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-11 |
| Decision Date | 1983-10-14 |