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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K173587
Device Name Magseed Magnetic Marker Systtem
Applicant
Endomagnetics Ltd.,
The Jeffreys Bldg., Cowley Rd.
Cambridge,  GB CB4 0WS
Applicant Contact Andrew Shawcross
Correspondent
Endomagnetics Ltd.,
The Jeffreys Bldg., Cowley Rd.
Cambridge,  GB CB4 0WS
Correspondent Contact Andrew Shawcross
Regulation Number878.4300
Classification Product Code
NEU  
Date Received11/20/2017
Decision Date 02/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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