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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 K222832
Device Name Sentimag System
Applicant
Endomagnetics Ltd
330 Cambridge Science Park, Milton Road
Cambridge,  GB CB4 0WN
Applicant Contact Mehryar Behizad
Correspondent
Endomagnetics Ltd
330 Cambridge Science Park, Milton Road
Cambridge,  GB CB4 0WN
Correspondent Contact Mehryar Behizad
Regulation Number878.4300
Classification Product Code
NEU  
Date Received09/20/2022
Decision Date 01/21/2023
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
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