The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Floor Mount Tubestand Performer, 6610.101/s-9109.
| Device ID | K912517 |
| 510k Number | K912517 |
| Device Name: | FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109 |
| Classification | System, X-ray, Stationary |
| 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 | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-06 |
| Decision Date | 1991-09-19 |