FDA 510(k) Application Details - K051421

Device Classification Name Marker, Radiographic, Implantable

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510(K) Number K051421
Device Name Marker, Radiographic, Implantable
Applicant MEDICAL DEVICE TECHNOLOGIES, INC.
3600 SW 47TH AVENUE
GAINESVILLE, FL 32608 US
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Contact KRISTINE LIBERACKI
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Regulation Number 878.4300

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Classification Product Code NEU
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Date Received 06/01/2005
Decision Date 08/30/2005
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



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