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FDA 510(k) Application Details - K063193
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K063193
Device Name
Marker, Radiographic, Implantable
Applicant
CARBON MEDICAL TECHNOLOGIES, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact
ROBERT W JOHNSON
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
10/20/2006
Decision Date
11/21/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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