510(k) K993552

ISOSEED PD-103 by Bebig Isotopentechnik GmbH — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2000
Date Received
October 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type