The following data is part of a premarket notification filed by Summit Industries, Inc. with the FDA for Colli-matetm Model No. B800.
Device ID | K874687 |
510k Number | K874687 |
Device Name: | COLLI-MATETM MODEL NO. B800 |
Classification | Collimator, Manual, Radiographic |
Applicant | SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago, IL 60625 |
Contact | Jim Walsh |
Correspondent | Jim Walsh SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago, IL 60625 |
Product Code | IZX |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-13 |
Decision Date | 1987-12-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B307D8000 | K874687 | 000 |