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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 K232865
Device Name Magseed Pro Magnetic Marker System
Applicant
Endomagnetics Ltd.,
330 Cambridge Science Park, Milton Rd.
Cambridge,  GB CB4 0WS
Applicant Contact Mehryar Behizad
Correspondent
Endomagnetics Ltd.,
330 Cambridge Science Park, Milton Rd.
Cambridge,  GB CB4 0WS
Correspondent Contact Mehryar Behizad
Regulation Number878.4300
Classification Product Code
NEU  
Date Received09/15/2023
Decision Date 06/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT05142787
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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