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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 K150169
Device Name Sertera Biopsy Device
Applicant
Hologic, INC
250 Campus Drive
Marlborough,  MA  01752
Applicant Contact Brenda Geary
Correspondent
Hologic, INC
250 Campus Drive
Marlborough,  MA  01752
Correspondent Contact Brenda Geary
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/26/2015
Decision Date 08/14/2015
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
Recalls CDRH Recalls
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