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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K953950
Device Name FLUORO CATHETER
Applicant
Cmt Medical Technologies, Ltd.
Matam High Technology Center
Haifa,  IL 31905
Applicant Contact IMRE FARKASH
Correspondent
Cmt Medical Technologies, Ltd.
Matam High Technology Center
Haifa,  IL 31905
Correspondent Contact IMRE FARKASH
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/22/1995
Decision Date 09/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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