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510(k) K222832

Sentimag System by Endomagnetics Ltd., — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2023
Date Received
September 20, 2022
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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  • K153044 — Sentimag System, Sentimark Magnetic Marker Systerm (March 2, 2016)

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