FDA 510(k) Application Details - K032594

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K032594
Device Name	Accelerator, Linear, Medical
Applicant	WELLHOFER DOSIMETRIE 3150 STAGE POST DR. SUITE 110 BARTLETT, TN 38133 US Other 510(k) Applications for this Company
Contact	MARK MARSICO 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	08/22/2003
Decision Date	09/05/2003
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	Y
Expedited Review