FDA 510(k) Application Details - K000349

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K000349
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	STRYKER LEIBINGER 4100 EAST MILHAM AVE. KALAMAZOO, MI 49001 US Other 510(k) Applications for this Company
Contact	KRISTYN R KELLEY 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	02/03/2000
Decision Date	05/03/2000
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