FDA 510(k) Application Details - K131150

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K131150
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	CURA MEDICAL TECHNOLOGIES, LLC 23 RANCHO CIRCLE LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	THOMAS H FARIS Other 510(k) Applications for this Contact
Regulation Number	892.5710   More FDA Info for this Regulation Number
Classification Product Code	IXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2013
Decision Date	07/30/2013
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