Magseed Magnetic Marker System

Temporary Tissue Marker

ENDOMAGNETICS LTD

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

Pre-market Notification Details

Device IDK163541
510k NumberK163541
Device Name:Magseed Magnetic Marker System
ClassificationTemporary Tissue Marker
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 CodePBY  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-16
Decision Date2017-01-13
Summary:summary

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