K791969 is an FDA 510(k) clearance for the DYNACOR STERILE CLOSED SYS. DRAINAGE BAG. This device is classified as a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II - Special Controls, product code KNX).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979, 34 days after receiving the submission on October 2, 1979.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K791969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1979 |
| Decision Date | November 05, 1979 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNX — Collector, Urine, (and Accessories) For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |