K961074 is an FDA 510(k) clearance for the LIGHTSOURCE OR ILLUMINATOR. This device is classified as a Light, Surgical, Floor Standing (Class II - Special Controls, product code FSS).
Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on April 30, 1996, 43 days after receiving the submission on March 18, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K961074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1996 |
| Decision Date | April 30, 1996 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FSS — Light, Surgical, Floor Standing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |