FDA 510(k) Application Details - K040553

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K040553
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	DIREX SYSTEMS CORP. 11 MERCER RD. BUSINESS PARK NATICK, MA 01760 US Other 510(k) Applications for this Company
Contact	LARISA GERSHTEIN 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	03/02/2004
Decision Date	04/01/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review