FDA 510(k) Application Details - K984235

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K984235
Device Name	Source, Brachytherapy, Radionuclide
Applicant	INTERNATIONAL BRACHYTHERAPY, INC. 6000 LIVE OAK PKWY., #107 NORCROSS, GA 30093 US Other 510(k) Applications for this Company
Contact	RUTH FEICHT 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	11/25/1998
Decision Date	06/09/1999
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