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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K102768
Device Name SECRMARK BIOPSY SITE MARKING SYSTEM
Applicant
Hologic, Inc.
6100 Technology Center Dr.
Indianapolis,  IN  46278
Applicant Contact ALYSSA M LOBO
Correspondent
Hologic, Inc.
6100 Technology Center Dr.
Indianapolis,  IN  46278
Correspondent Contact ALYSSA M LOBO
Regulation Number878.4300
Classification Product Code
NEU  
Date Received09/24/2010
Decision Date 12/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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