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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 K153189
Device Name Beacon Tissue Marker (SE)
Applicant
Scion Medical Technologies, LLC
4613 W. Chester Pike
Newtown Square,  PA  19073
Applicant Contact LOUIS LI
Correspondent
Scion Medical Technologies, LLC
4613 W. Chester Pike
Newtown Square,  PA  19073
Correspondent Contact LOUIS LI
Regulation Number878.4300
Classification Product Code
NEU  
Date Received11/03/2015
Decision Date 12/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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