The following data is part of a premarket notification filed by Denar Corp. with the FDA for Accurad-200 System & Accurad-300 Plus System.
| Device ID | K925705 |
| 510k Number | K925705 |
| Device Name: | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM |
| Classification | Holder, Head, Radiographic |
| Applicant | DENAR CORP. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Contact | Thomas J Muldoon |
| Correspondent | Thomas J Muldoon DENAR CORP. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Product Code | IWY |
| CFR Regulation Number | 892.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1992-12-28 |