FDA 510(k) Application Details - K991319

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K991319
Device Name	Accelerator, Linear, Medical
Applicant	ORFIT INDUSTRIES 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA NOLTE Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/1999
Decision Date	09/21/1999
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