FDA 510(k) Application Details - K972271

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K972271
Device Name	Source, Brachytherapy, Radionuclide
Applicant	ML STRATEGIES, INC. ONE FINANCIAL CENTER BOSTON, MA 02111 US Other 510(k) Applications for this Company
Contact	ALLAN M GREEN 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	06/18/1997
Decision Date	10/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review