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FDA 510(k) Application Details - K051421
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4300
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Classification Product Code
NEU
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More FDA Info for this Product Code
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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