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FDA 510(k) Application Details - K073095
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K073095
Device Name
Marker, Radiographic, Implantable
Applicant
SOMATEX MEDICAL TECHNOLOGIES GMBH
1480 CAMBRIDGE STREET
CAMBRIDGE, MA 02139 US
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Contact
SUSANNE RAAB
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
11/01/2007
Decision Date
03/19/2008
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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