The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Modified C-dak.
| Device ID | K844185 |
| 510k Number | K844185 |
| Device Name: | MODIFIED C-DAK |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Albert E Jarvis |
| Correspondent | Albert E Jarvis CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-29 |
| Decision Date | 1985-01-03 |