FDA 510(k) Application Details - K090321

Device Classification Name	Conformal Brachytherapy Source   More FDA Info for this Device
510(K) Number	K090321
Device Name	Conformal Brachytherapy Source
Applicant	RI CONSULTANTS, LLC 1 CHAGNON LANE HUDSON, NH 03051 US Other 510(k) Applications for this Company
Contact	THOMAS GOLEMBESKI Other 510(k) Applications for this Contact
Regulation Number	892.5730   More FDA Info for this Regulation Number
Classification Product Code	ONL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/09/2009
Decision Date	05/27/2009
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