FDA 510(k) Application Details - K031273

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K031273
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 SINGER ISLAND, FL 33404 US Other 510(k) Applications for this Company
Contact	GREG WIITA 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	04/22/2003
Decision Date	07/15/2003
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