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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 K202294
Device Name Affirm Contrast Biopsy
Applicant
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact Kate Brown
Correspondent
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact Kate Brown
Regulation Number892.1710
Classification Product Code
IZH  
Subsequent Product Code
MUE  
Date Received08/13/2020
Decision Date 10/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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