The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Redy 2000 System (therapeutic Plasma Exchange Option And Monitoring Line Y-connector).
| Device ID | K954623 |
| 510k Number | K954623 |
| Device Name: | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | GAMBRO HEALTHCARE 3631 SW 54TH ST. Oklahoma City, OK 73119 |
| Contact | Mathew M Hull |
| Correspondent | Mathew M Hull GAMBRO HEALTHCARE 3631 SW 54TH ST. Oklahoma City, OK 73119 |
| Product Code | FKT |
| CFR Regulation Number | 876.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-05 |
| Decision Date | 1996-08-28 |