510(k) K082264

CONTURA LUMEN MARKER by Senorx, Inc. — Product Code JAQ

Clearance Details

Decision
SESU ()
Decision Date
September 12, 2008
Date Received
August 11, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type