FDA 510(k) Application Details - K973363

Device Classification Name	Source, Isotope, Sealed, Gold, Titanium, Platinum   More FDA Info for this Device
510(K) Number	K973363
Device Name	Source, Isotope, Sealed, Gold, Titanium, Platinum
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	IWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/1997
Decision Date	07/02/1998
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