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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Manual, Radiographic
510(k) Number K874687
Device Name COLLI-MATETM MODEL NO. B800
Applicant
Summit Industries, Inc.
2901 W Lawrence Ave.
Chicago,  IL  60625
Applicant Contact JIM WALSH
Correspondent
Summit Industries, Inc.
2901 W Lawrence Ave.
Chicago,  IL  60625
Correspondent Contact JIM WALSH
Regulation Number892.1610
Classification Product Code
IZX  
Date Received11/13/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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