The following data is part of a premarket notification filed by Summit Industries, Inc. with the FDA for Rdiographic Wall Holder Or Film Receptor.
Device ID | K851440 |
510k Number | K851440 |
Device Name: | RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR |
Classification | Holder, Radiographic Cassette, Wall-mounted |
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 | IXY |
CFR Regulation Number | 892.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-10 |
Decision Date | 1985-06-05 |