FDA 510(k) Application Details - K153189

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K153189
Device Name	Marker, Radiographic, Implantable
Applicant	SCION MEDICAL TECHNOLOGIES, LLC 4613 WEST CHESTER PIKE NEWTOWN SQUARE, PA 19073 US Other 510(k) Applications for this Company
Contact	LOUIS LI Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	NEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2015
Decision Date	12/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review