FDA 510(k) Application Details - K971001

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K971001
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	MEDIZINTECHNIK, GMBH 12300 TWINBROOK PARKWAY, SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY 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	03/19/1997
Decision Date	06/13/1997
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