The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Lightsource Or Illuminator.
| Device ID | K980166 |
| 510k Number | K980166 |
| Device Name: | LIGHTSOURCE OR ILLUMINATOR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Contact | Kim Reek |
| Correspondent | Kim Reek CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Product Code | HET |
| Subsequent Product Code | FCR |
| Subsequent Product Code | FCW |
| Subsequent Product Code | FFS |
| Subsequent Product Code | HBI |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-04-01 |