The following data is part of a premarket notification filed by Amisco Trading Corp. with the FDA for Hemodialysis Venous & Arterial Set.
| Device ID | K812622 |
| 510k Number | K812622 |
| Device Name: | HEMODIALYSIS VENOUS & ARTERIAL SET |
| Classification | Solution-test Standard-conductivity, Dialysis |
| Applicant | AMISCO TRADING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKH |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-15 |
| Decision Date | 1981-09-24 |