The following data is part of a premarket notification filed by Knochen Dental Laboratory with the FDA for Deluxe Wall-mounted Cephalometer.
| Device ID | K834559 |
| 510k Number | K834559 |
| Device Name: | DELUXE WALL-MOUNTED CEPHALOMETER |
| Classification | Holder, Head, Radiographic |
| Applicant | KNOCHEN DENTAL LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWY |
| CFR Regulation Number | 892.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-28 |
| Decision Date | 1984-02-21 |