The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Fresenius Puristeril 340 (tm).
| Device ID | K874573 |
| 510k Number | K874573 |
| Device Name: | FRESENIUS PURISTERIL 340 (TM) |
| Classification | Dialyzer Reprocessing System |
| Applicant | SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Scott N Walker |
| Correspondent | Scott N Walker SERATRONICS, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-05 |
| Decision Date | 1988-04-25 |