The following data is part of a premarket notification filed by Summit Industries, Inc. with the FDA for Xma Integrated Table.
Device ID | K850118 |
510k Number | K850118 |
Device Name: | XMA INTEGRATED TABLE |
Classification | Table, Radiographic, Stationary Top |
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 | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-14 |
Decision Date | 1985-04-09 |