The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Drs 4 Nd Dialyzer Reprocessing System.
| Device ID | K944539 |
| 510k Number | K944539 |
| Device Name: | DRS 4 ND DIALYZER REPROCESSING SYSTEM |
| Classification | Dialyzer Reprocessing System |
| Applicant | SERATRONICS, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Scott N Walker |
| Correspondent | Scott N Walker SERATRONICS, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1995-11-29 |