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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K982427
Device Name TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
Applicant
Trex Medical Corp.
2000 S. 25th Ave.
Broadview,  IL  60153
Applicant Contact WILLIAM T COUSINS
Correspondent
Trex Medical Corp.
2000 S. 25th Ave.
Broadview,  IL  60153
Correspondent Contact WILLIAM T COUSINS
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/13/1998
Decision Date 09/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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