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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K180233
Device Name Eviva Stereotactic Guided Breast Biopsy System
Applicant
Hologic, Inc.
250 Campus Dr.
Marlborough,  MA  01752
Applicant Contact Brenda M Geary
Correspondent
Hologic, Inc.
250 Campus Dr.
Marlborough,  MA  01752
Correspondent Contact Brenda M Geary
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/29/2018
Decision Date 04/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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