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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, Mammographic
510(k) Number K984092
Device Name PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
Applicant
Trex Medical Corp.
445 Oak St.
Copiague,  NY  11726 -2719
Applicant Contact WALTER F SCHNEIDER
Correspondent
Trex Medical Corp.
445 Oak St.
Copiague,  NY  11726 -2719
Correspondent Contact WALTER F SCHNEIDER
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/16/1998
Decision Date 02/05/1999
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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