The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Cermax300 Lightsource.
| Device ID | K981469 |
| 510k Number | K981469 |
| Device Name: | CERMAX300 LIGHTSOURCE |
| Classification | Light, Surgical, Floor Standing |
| Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Contact | Kim Reed |
| Correspondent | Kim Reed CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-23 |
| Decision Date | 1998-07-09 |