The following data is part of a premarket notification filed by Medionics International, Inc. with the FDA for Easy Care And Tubing Sets.
| Device ID | K994218 |
| 510k Number | K994218 |
| Device Name: | EASY CARE AND TUBING SETS |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. Markham, Ontario, CA L6e 1a5 |
| Contact | Mahesh A Garwal |
| Correspondent | Mahesh A Garwal MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. Markham, Ontario, CA L6e 1a5 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-15 |
| Decision Date | 2000-02-10 |