FDA 510(k) Application Details - K982120

Device Classification Name System, Image Processing, Radiological

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510(K) Number K982120
Device Name System, Image Processing, Radiological
Applicant TREX MEDICAL CORP.
2000 SOUTH 25TH AVE.
BROADVIEW, IL 60153 US
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Contact WILLIAM T COUSINS
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/16/1998
Decision Date 09/10/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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