The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Video Camera/lightsource Combination Unit Model Vcl-150.
| Device ID | K980350 |
| 510k Number | K980350 |
| Device Name: | VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-28 |
| Decision Date | 1998-04-28 |