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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Stationary Top
510(k) Number K850118
Device Name XMA INTEGRATED TABLE
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 Number892.1980
Classification Product Code
IXQ  
Date Received01/14/1985
Decision Date 04/09/1985
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
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