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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 K890784
Device Name MAMMOMAT C
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin,  NJ  08830
Original Contact harry k schwill
Regulation Number892.1710
Classification Product Code
IZH  
Date Received02/15/1989
Decision Date 05/03/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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