FDA 510(k) Application Details - K030558

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K030558
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	PROXIMA THERAPEUTICS, INC. 2555 MARCONI DRIVE, SUITE 220 ALPHARETTA, GA 30005-2066 US Other 510(k) Applications for this Company
Contact	MARTINE D SCHNEIDER Other 510(k) Applications for this Contact
Regulation Number	892.5700   More FDA Info for this Regulation Number
Classification Product Code	JAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2003
Decision Date	05/21/2003
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	N
Expedited Review