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 |
|