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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 K914328
Device Name MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact STEPHEN K DEOL
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact STEPHEN K DEOL
Regulation Number892.1710
Classification Product Code
IZH  
Date Received09/27/1991
Decision Date 12/02/1991
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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