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FDA 510(k) Application Details - K063238
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K063238
Device Name
Marker, Radiographic, Implantable
Applicant
INRAD
4375 DONKER COURT S.E.
KENTWOOD, MI 49512 US
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Contact
MELISSA LALOMIA
Other 510(k) Applications for this Contact
Regulation Number
878.4300
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Classification Product Code
NEU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/26/2006
Decision Date
01/30/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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