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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
Applicant
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact GAIL YAEKER-DAUNIS
Correspondent
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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