The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Intraoral Video Scope And Window Tube.
| Device ID | K951019 |
| 510k Number | K951019 |
| Device Name: | INTRAORAL VIDEO SCOPE AND WINDOW TUBE |
| Classification | Unit, Operative Dental |
| 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 | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-07 |
| Decision Date | 1995-05-10 |