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FDA 510(k) Application Details - K152586
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K152586
Device Name
Marker, Radiographic, Implantable
Applicant
Covidien LLC
15 HAMPSHIRE STREET
MANSFIELD, MA 02048 US
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Contact
RACHEL SILVA
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
09/10/2015
Decision Date
12/30/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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