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 |