COLLI-MATETM MODEL NO. B800

Collimator, Manual, Radiographic

SUMMIT INDUSTRIES, INC.

The following data is part of a premarket notification filed by Summit Industries, Inc. with the FDA for Colli-matetm Model No. B800.

Pre-market Notification Details

Device IDK874687
510k NumberK874687
Device Name:COLLI-MATETM MODEL NO. B800
ClassificationCollimator, Manual, Radiographic
Applicant SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago,  IL  60625
ContactJim Walsh
CorrespondentJim Walsh
SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago,  IL  60625
Product CodeIZX  
CFR Regulation Number892.1610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-13
Decision Date1987-12-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B307D8000 K874687 000

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