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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K921129
Device Name MRX-700
Applicant
Mrx-Ray Tube Corp.
320 Westway Pl.
Suite 520
Arlington,  TX  76018
Applicant Contact RICHARD BELL
Correspondent
Mrx-Ray Tube Corp.
320 Westway Pl.
Suite 520
Arlington,  TX  76018
Correspondent Contact RICHARD BELL
Regulation Number892.1760
Classification Product Code
ITY  
Date Received03/10/1992
Decision Date 10/05/1992
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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