FDA 510(k) Application Details - K060187

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K060187
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	TOPSLANE INTERNATIONAL, LLC 15375 ROOSEVELT BLVD. SUITE # 300 CLEARWATER, FL 33760 US Other 510(k) Applications for this Company
Contact	JIM MARSH 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	01/24/2006
Decision Date	07/27/2006
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