The following data is part of a premarket notification filed by Medionics International Ltd. with the FDA for Microstar Vci.
| Device ID | K831766 |
| 510k Number | K831766 |
| Device Name: | MICROSTAR VCI |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | MEDIONICS INTERNATIONAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-01 |
| Decision Date | 1983-10-14 |