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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 SOUTH 25TH AVE.
BROADVIEW,  IL  60153
Applicant Contact WILLIAM T COUSINS
Correspondent
TREX MEDICAL CORP.
2000 SOUTH 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
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