The following data is part of a premarket notification filed by General Electric Co. with the FDA for Intra Oral X-ray Cones.
| Device ID | K771748 |
| 510k Number | K771748 |
| Device Name: | INTRA ORAL X-RAY CONES |
| Classification | Cone, Radiographic, Lead-lined |
| Applicant | GENERAL ELECTRIC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAH |
| CFR Regulation Number | 872.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-15 |
| Decision Date | 1977-09-28 |