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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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More FDA Info for this Product Code
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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