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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 K964069
Device Name DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood ave. south
iselin,  NJ  08830
Original Contact kathleen rutherford
Regulation Number892.1710
Classification Product Code
IZH  
Date Received10/10/1996
Decision Date 05/08/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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