510(k) K060187

TOPSLANE DMLC by Topslane International, LLC — Product Code IXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2006
Date Received
January 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type