FDA 510(k) Application Details - K973184

Device Classification Name	System, Applicator, Radionuclide, Manual   More FDA Info for this Device
510(K) Number	K973184
Device Name	System, Applicator, Radionuclide, Manual
Applicant	PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 INDIANAPOLIS, IN 46202 US Other 510(k) Applications for this Company
Contact	JOSEPH L MARK Other 510(k) Applications for this Contact
Regulation Number	892.5650   More FDA Info for this Regulation Number
Classification Product Code	IWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/1997
Decision Date	11/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review