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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, Mobile
510(k) Number K992229
Device Name MXU-125 OR TMX-125
Applicant
Trex Medical Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact KELVIN BURROUGHS
Correspondent
Trex Medical Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact KELVIN BURROUGHS
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/02/1999
Decision Date 08/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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