K934337 is an FDA 510(k) clearance for the CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE, a Light, Surgical, Endoscopic (Class II — Special Controls, product code FSW), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on November 18, 1993, 72 days after receiving the submission on September 7, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K934337 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 1993 |
| Decision Date | November 18, 1993 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FSW — Light, Surgical, Endoscopic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |