FDA 510(k) Application Details - K132097

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K132097
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	BEST MEDICAL INTERNATIONAL, INC. 7643 FULLERTON RD. SPRINGFIELD, VA 22153 US Other 510(k) Applications for this Company
Contact	DHARMENDRA THAKUR 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	07/08/2013
Decision Date	09/30/2013
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