The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gxp Dental X-ray Processor.
| Device ID | K932675 |
| 510k Number | K932675 |
| Device Name: | GXP DENTAL X-RAY PROCESSOR |
| Classification | Scissors, Surgical Tissue, Dental |
| Applicant | GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | James E Kettner |
| Correspondent | James E Kettner GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | EGN |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1993-07-26 |