The following data is part of a premarket notification filed by Gary D. Keller with the FDA for Keller Cephalometric Device.
| Device ID | K850197 |
| 510k Number | K850197 |
| Device Name: | KELLER CEPHALOMETRIC DEVICE |
| Classification | Holder, Head, Radiographic |
| Applicant | GARY D. KELLER GRAYSON BANK BUILDING SUITE 201 - 400 NORTH Sherman, TX 75090 |
| Product Code | IWY |
| CFR Regulation Number | 892.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-18 |
| Decision Date | 1985-03-22 |