FDA 510(k) Application Details - K050090

Device Classification Name Marker, Radiographic, Implantable

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510(K) Number K050090
Device Name Marker, Radiographic, Implantable
Applicant SENORX, INC.
11 COLUMBIA, SUITE A
ALISO VIEJO, CA 92656 US
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Contact AMY BOUCLY
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Regulation Number 878.4300

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Classification Product Code NEU
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Date Received 01/14/2005
Decision Date 02/07/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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