FDA 510(k) Application Details - K983917

Device Classification Name	System, Radiation Therapy, Radionuclide   More FDA Info for this Device
510(K) Number	K983917
Device Name	System, Radiation Therapy, Radionuclide
Applicant	THERATRONICS, INC. 413 MARCH ROAD P.O. BOX 13140 KANATA ONTARIO K2K 2B7 CA Other 510(k) Applications for this Company
Contact	E.S. MARTELL Other 510(k) Applications for this Contact
Regulation Number	892.5750   More FDA Info for this Regulation Number
Classification Product Code	IWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/1998
Decision Date	12/04/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review