FDA 510(k) Application Details - K021343

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K021343
Device Name	Source, Brachytherapy, Radionuclide
Applicant	BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH ROBERT-ROSSLE STR 10 BERLIN D-131125 DE Other 510(k) Applications for this Company
Contact	SVEN LANGER Other 510(k) Applications for this Contact
Regulation Number	892.5730   More FDA Info for this Regulation Number
Classification Product Code	KXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2002
Decision Date	05/20/2002
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