The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Lightsource Or Illuminator Model I-100.
| Device ID | K983277 |
| 510k Number | K983277 |
| Device Name: | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| 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 | HBI |
| Subsequent Product Code | FCR |
| Subsequent Product Code | FCW |
| Subsequent Product Code | FFS |
| Subsequent Product Code | HET |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-17 |
| Decision Date | 1998-12-16 |