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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 K133697
Device Name BREAST-MED TISSUE MARKER
Applicant
Breast-Med, Inc.
1745 Bridgewater Rd.
Golden Valley,  MN  55422
Applicant Contact MICHAEL NELSON
Correspondent
Breast-Med, Inc.
1745 Bridgewater Rd.
Golden Valley,  MN  55422
Correspondent Contact MICHAEL NELSON
Regulation Number878.4300
Classification Product Code
NEU  
Date Received12/03/2013
Decision Date 04/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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