The following data is part of a premarket notification filed by Summit Industries, Inc. with the FDA for Floor To Wall Or Floor To Ceiling Tubestand;radiog.
| Device ID | K850198 |
| 510k Number | K850198 |
| Device Name: | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago, IL 60625 |
| Contact | Jim K Walsh |
| Correspondent | Jim K Walsh SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago, IL 60625 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-18 |
| Decision Date | 1985-05-14 |