FDA 510(k) Application Details - K963451

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K963451
Device Name	Accelerator, Linear, Medical
Applicant	TOPSLANE 824 RUTH DR. PLEASNAT HILL, CA 94523 US Other 510(k) Applications for this Company
Contact	ANN ZENG 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	09/03/1996
Decision Date	08/05/1997
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