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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomographic
510(k) Number K924443
Device Name RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE
Applicant
Control-X, Inc.
2289 Westbrooke Dr.
Columbus,  OH  43228
Applicant Contact ZSIGMOND KOVACS
Correspondent
Control-X, Inc.
2289 Westbrooke Dr.
Columbus,  OH  43228
Correspondent Contact ZSIGMOND KOVACS
Regulation Number892.1740
Classification Product Code
IZF  
Date Received09/01/1992
Decision Date 02/05/1993
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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