The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for 480 High-flow Ultrafiltration Control Dialysate.
| Device ID | K880459 |
| 510k Number | K880459 |
| Device Name: | 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Gordon W Robertson |
| Correspondent | Gordon W Robertson CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-03 |
| Decision Date | 1988-04-13 |