Magseed Magnetic Marker Systtem

Marker, Radiographic, Implantable

Endomagnetics Ltd.

The following data is part of a premarket notification filed by Endomagnetics Ltd. with the FDA for Magseed Magnetic Marker Systtem.

Pre-market Notification Details

Device IDK173587
510k NumberK173587
Device Name:Magseed Magnetic Marker Systtem
ClassificationMarker, Radiographic, Implantable
Applicant Endomagnetics Ltd. The Jeffreys Building, Cowley Road Cambridge,  GB Cb4 0ws
ContactAndrew Shawcross
CorrespondentAndrew Shawcross
Endomagnetics Ltd. The Jeffreys Building, Cowley Road Cambridge,  GB Cb4 0ws
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-20
Decision Date2018-02-16
Summary:summary

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