K945567 is an FDA 510(k) clearance for the QC CAP, a Set, Administration, For Peritoneal Dialysis, Disposable (Class II — Special Controls, product code KDJ), submitted by Medionics International, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on February 7, 1995, 133 days after receiving the submission on September 27, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K945567 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 1994 |
| Decision Date | February 07, 1995 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDJ — Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |