FDA 510(k) Application Details - K961140

Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified

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510(K) Number K961140
Device Name System, X-Ray, Fluoroscopic, Image-Intensified
Applicant CMT MEDICAL TECHNOLOGIES, LTD.
MATAM HIGH TECHNOLOGY CENTER
HAIFA 31905 IL
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Contact IMRE FARKASH
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Regulation Number 892.1650

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Classification Product Code JAA
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Date Received 03/21/1996
Decision Date 09/20/1996
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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