FDA 510(k) Application Details - K032157

Device Classification Name System, Image Processing, Radiological

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510(K) Number K032157
Device Name System, Image Processing, Radiological
Applicant TELEMIS S.A.
7560 LINDBERGH DRIVE
GAITHERSBURG, MD 20879 US
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Contact THOMAS J BOUCHARD
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/14/2003
Decision Date 09/24/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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