K933369 is an FDA 510(k) clearance for the CUDA PRODUCTS CORP. LIGHTSOURCES, a Light Source, Fiberoptic, Routine (Class II — Special Controls, product code FCW), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on January 3, 1994, 178 days after receiving the submission on July 9, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K933369 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 09, 1993 |
| Decision Date | January 03, 1994 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCW — Light Source, Fiberoptic, Routine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |