FDA 510(k) Application Details - K991578

Device Classification Name System, Image Processing, Radiological

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510(K) Number K991578
Device Name System, Image Processing, Radiological
Applicant CMT MEDICAL TECHNOLOGIES, LTD.
MATAM HIGH TECHNOLOGY CENTER
HAIFA 31905 IL
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Contact YESHAYAHU RAZ
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/06/1999
Decision Date 06/03/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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