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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 K100692
Device Name DIGITAL SPOT MAMMOGRAPHY SYSTEM
Original Applicant
HOLOGIC, INC.
36 apple ridge road
danbury,  CT  06810
Original Contact gail yaeker-daunis
Regulation Number892.1710
Classification Product Code
IZH  
Date Received03/10/2010
Decision Date 04/06/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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