510(k) K150636

VariSeed 9.0 by Varian Medical Systems, Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2015
Date Received
March 11, 2015
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