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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 K123911
Device Name SENOMARK ULTRA BREAST TISSUE MARKER
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Applicant Contact SARAH MCCARTNEY
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Correspondent Contact SARAH MCCARTNEY
Regulation Number878.4300
Classification Product Code
NEU  
Date Received12/19/2012
Decision Date 01/10/2013
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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