The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Acute Renal Dialysis Tray.
| Device ID | K790353 |
| 510k Number | K790353 |
| Device Name: | ACUTE RENAL DIALYSIS TRAY |
| Classification | Tray, Start/stop (including Contents), Dialysis |
| Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-22 |
| Decision Date | 1979-04-20 |