The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Cd Home Dialyservice Hemodialysis Tray.
| Device ID | K925654 |
| 510k Number | K925654 |
| Device Name: | CD HOME DIALYSERVICE HEMODIALYSIS TRAY |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Diana Uhl |
| Correspondent | Diana Uhl CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-09 |
| Decision Date | 1994-03-30 |