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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, Mammographic
510(k) Number K003473
Device Name DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM
Applicant
Elscintec Systems , Ltd.
Matam-Advanced Tech. Center
Haifa,  IL 31000
Applicant Contact ELLIOT MARSHALL
Correspondent
Elscintec Systems , Ltd.
Matam-Advanced Tech. Center
Haifa,  IL 31000
Correspondent Contact ELLIOT MARSHALL
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/08/2000
Decision Date 11/28/2000
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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