The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Hemoperfusion Procedure W/redy 2000.
| Device ID | K842513 |
| 510k Number | K842513 |
| Device Name: | HEMOPERFUSION PROCEDURE W/REDY 2000 |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | ORGANON TEKNIKA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKT |
| CFR Regulation Number | 876.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-26 |
| Decision Date | 1984-09-12 |