The following data is part of a premarket notification filed by Medionics International Ltd. with the FDA for Capd Disposable Y System - Dy Set.
| Device ID | K883393 |
| 510k Number | K883393 |
| Device Name: | CAPD DISPOSABLE Y SYSTEM - DY SET |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | MEDIONICS INTERNATIONAL LTD. 1271 DENISON ST. UNIT 49, MARKHAM Ontario, Canada, CA L3r 4b5 |
| Contact | Mahesh Agarwal |
| Correspondent | Mahesh Agarwal MEDIONICS INTERNATIONAL LTD. 1271 DENISON ST. UNIT 49, MARKHAM Ontario, Canada, CA L3r 4b5 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-09 |
| Decision Date | 1988-11-03 |