Beacon Fine Needle Fiducial System

Marker, Radiographic, Implantable

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Beacon Fine Needle Fiducial System.

Pre-market Notification Details

Device IDK152586
510k NumberK152586
Device Name:Beacon Fine Needle Fiducial System
ClassificationMarker, Radiographic, Implantable
Applicant Covidien LLC 15 HAMPSHIRE STREET Mansfield,  MA  02048
ContactRachel Silva
CorrespondentRachel Silva
Covidien LLC 15 HAMPSHIRE STREET Mansfield,  MA  02048
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-10
Decision Date2015-12-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10855208005176 K152586 000
10855208005169 K152586 000
00855208005155 K152586 000
00855208005148 K152586 000

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