The following data is part of a premarket notification filed by Gary E. Hall, Dds with the FDA for Duoceph.
| Device ID | K864527 |
| 510k Number | K864527 |
| Device Name: | DUOCEPH |
| Classification | Holder, Head, Radiographic |
| Applicant | GARY E. HALL, DDS 46850 NORTH TERRITORIAL Plymouth, MI 48170 |
| Product Code | IWY |
| CFR Regulation Number | 892.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-17 |
| Decision Date | 1987-01-07 |