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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name full field digital, system, x-ray, mammographic
510(k) Number K123873
Device Name CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
Applicant
HOLOGIC, INC.
35 CROSBY DR.
BEDFORD,  MA  01730
Applicant Contact DEBORAH THOMAS
Correspondent
HOLOGIC, INC.
35 CROSBY DR.
BEDFORD,  MA  01730
Correspondent Contact DEBORAH THOMAS
Regulation Number892.1715
Classification Product Code
MUE  
Date Received12/17/2012
Decision Date 01/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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