The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Suitcase Kidney Hemodialysis System.
| Device ID | K781405 |
| 510k Number | K781405 |
| Device Name: | SUITCASE KIDNEY HEMODIALYSIS SYSTEM |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-14 |
| Decision Date | 1978-12-07 |