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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 K140835
Device Name GENERAL AND PLASTIC SURGERY
Applicant
Scion Medical Technologies, LLC
90 Oak St.
Newton,  MA  02464
Applicant Contact CHRIS LEWIS
Correspondent
Scion Medical Technologies, LLC
90 Oak St.
Newton,  MA  02464
Correspondent Contact CHRIS LEWIS
Regulation Number878.4300
Classification Product Code
NEU  
Date Received04/02/2014
Decision Date 05/20/2014
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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