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510(k) K241762

OneMark by View Point Medical — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2024
Date Received
June 20, 2024
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

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