The following data is part of a premarket notification filed by Medionics International, Inc. with the FDA for Qc Cap.
| Device ID | K945567 |
| 510k Number | K945567 |
| Device Name: | QC CAP |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. Markham, Ontario, CA L6e 1a5 |
| Contact | Mahesh Agarwal |
| Correspondent | Mahesh Agarwal MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. Markham, Ontario, CA L6e 1a5 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1995-02-07 |