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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K850198
Device Name FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG
Applicant
Summit Industries, Inc.
2901 W Lawrence Ave.
Chicago,  IL  60625
Applicant Contact JIM K WALSH
Correspondent
Summit Industries, Inc.
2901 W Lawrence Ave.
Chicago,  IL  60625
Correspondent Contact JIM K WALSH
Regulation Number892.1770
Classification Product Code
IYB  
Date Received01/18/1985
Decision Date 05/14/1985
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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