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510(k) K251989

VizMark Preloaded Tissue Marker Device (VM-0001) by Breast-Med, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
June 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Breast-Med, Inc.

  • K133697 — BREAST-MED TISSUE MARKER (April 10, 2015)

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