FDA 510(k) Application Details - K241762

Device Classification Name Marker, Radiographic, Implantable

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510(K) Number K241762
Device Name Marker, Radiographic, Implantable
Applicant View Point Medical
6451 El Camino Real, Suite A
Carlsbad, CA 92009 US
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Contact Tom Kane
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Regulation Number 878.4300

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Classification Product Code NEU
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Date Received 06/20/2024
Decision Date 09/16/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241762


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