K883610 is an FDA 510(k) clearance for the LAKE FOLEY CATHETERIZATION TRAY. This device is classified as a Urinary Drainage Collection Kit, For Indwelling Catheter (Class II - Special Controls, product code FCN).
Submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 12, 1988, 51 days after receiving the submission on August 22, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K883610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1988 |
| Decision Date | October 12, 1988 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FCN — Urinary Drainage Collection Kit, For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |