FDA 510(k) Application Details - K142243

Device Classification Name	More FDA Info for this Device
510(K) Number	K142243
Device Name	LessRay with Tracking
Applicant	SAFERAY SPINE, LLC 5102 Durham Chapel Hill Blvd. Suite 203 Durham, NC 27707 US Other 510(k) Applications for this Company
Contact	Michael Alrutz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2014
Decision Date	11/18/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review