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FDA 510(k) Application Details - K131654
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K131654
Device Name
Marker, Radiographic, Implantable
Applicant
SENORX, INC.
1625 West 3rd Street
Tempe, AZ 85281 US
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Contact
SARAH MCCARTNEY
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
06/06/2013
Decision Date
06/27/2013
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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