The following data is part of a premarket notification filed by Kaycor Intl., Ltd. with the FDA for Panoura Ultra Pan And Panoura Ultra Pan/ceph Panoramic/cephalometric X-ray Unit.
| Device ID | K965072 |
| 510k Number | K965072 |
| Device Name: | PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | KAYCOR INTL., LTD. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
| Contact | Keith R Kretchmer |
| Correspondent | Keith R Kretchmer KAYCOR INTL., LTD. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-01-27 |
| Summary: | summary |