FDA 510(k) Application Details - K991815

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K991815
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	OUR SCIENTIFIC INTL., INC. 5870 STONERIDGE DR. PLEASANTVILLE, CA 94588 US Other 510(k) Applications for this Company
Contact	MARIO CABALLERO Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	MUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/1999
Decision Date	08/13/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review