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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, Tomography, Computed
510(k) Number K942040
Device Name MRX-280
Applicant
Mrx Corp.
320 Westway Pl.
Suite 520
Arlington,  TX  76018
Applicant Contact MITCH JENSEN
Correspondent
Mrx Corp.
320 Westway Pl.
Suite 520
Arlington,  TX  76018
Correspondent Contact MITCH JENSEN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/28/1994
Decision Date 07/05/1994
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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