The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Cuda Products Corp. Model Mx2-300 Lightsource.
| Device ID | K934337 |
| 510k Number | K934337 |
| Device Name: | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE |
| Classification | Light, Surgical, Endoscopic |
| Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Contact | Cynthia Arcusa |
| Correspondent | Cynthia Arcusa CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Product Code | FSW |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1993-11-18 |