FDA 510(k) Application Details - K981992

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K981992
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	MED-TEC,INC. 1401 8TH ST. S.E. P.O. BOX 320 ORANGE CITY, IA 51041 US Other 510(k) Applications for this Company
Contact	DONALD F RIIBE 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	06/08/1998
Decision Date	12/15/1998
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