The following data is part of a premarket notification filed by Medionics International Ltd. with the FDA for Selectra And Tubing Sets.
| Device ID | K910173 |
| 510k Number | K910173 |
| Device Name: | SELECTRA AND TUBING SETS |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | MEDIONICS INTERNATIONAL LTD. 114 ANDERSON AVENUE MARKHLAM, ONTARIO, Canada L6e 1a5, CA |
| Contact | Mahesh Agarwal |
| Correspondent | Mahesh Agarwal MEDIONICS INTERNATIONAL LTD. 114 ANDERSON AVENUE MARKHLAM, ONTARIO, Canada L6e 1a5, CA |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1992-01-13 |