FDA 510(k) Application Details - K973328

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K973328
Device Name	Source, Brachytherapy, Radionuclide
Applicant	INTERNATIONAL BRACHYTHERAPY, SA ZONE INDUSTRIELLE C SENEFFE 7180 BE Other 510(k) Applications for this Company
Contact	VINCENT E CONIGLIONE 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	09/04/1997
Decision Date	12/10/1998
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