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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 K153486
Device Name Affirm Prone Biopsy System
Applicant
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact Sarah Fairfield
Correspondent
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact Sarah Fairfield
Regulation Number892.1710
Classification Product Code
IZH  
Date Received12/04/2015
Decision Date 04/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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