The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Processor, Radiographic-film, Automatic, Dental.
| Device ID | K945682 |
| 510k Number | K945682 |
| Device Name: | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL |
| Classification | Processor, Radiographic-film, Automatic, 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 | EGY |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1995-02-09 |