The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Ultrx(tm) 850 Artificial Kidney.
| Device ID | K884353 |
| 510k Number | K884353 |
| Device Name: | ULTRX(TM) 850 ARTIFICIAL KIDNEY |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Ann Roadruck |
| Correspondent | Ann Roadruck CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-17 |
| Decision Date | 1988-12-08 |