The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Omniflex Overhead Tubecrane Cat.#s-9108/#6713.400.
| Device ID | K913121 |
| 510k Number | K913121 |
| Device Name: | OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 |
| Classification | Table, Radiologic |
| Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Contact | Oscar Khutoryansky |
| Correspondent | Oscar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Product Code | KXJ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1991-08-16 |