The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Cuda Products Corp. Model M300 (m-300) Lightsource.
| Device ID | K981962 |
| 510k Number | K981962 |
| Device Name: | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE |
| Classification | Light, Surgical, Floor Standing |
| Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Contact | Joseph Cuda |
| Correspondent | Joseph Cuda 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 | 1998-06-04 |
| Decision Date | 1998-08-18 |