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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 K251989
Device Name VizMark Preloaded Tissue Marker Device (VM-0001)
Applicant
Breast-Med, Inc.
10580 Wayzata Blvd.
Suite 150
Hopkins,  MN  55305
Applicant Contact Michael Nelson
Correspondent
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St, Paul,  MN  55110
Correspondent Contact Yidi Hou
Regulation Number878.4300
Classification Product Code
NEU  
Date Received06/27/2025
Decision Date 12/12/2025
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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