510(k) K081079

CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY by Senorx, Inc. — Product Code JAQ

Clearance Details

Decision
SESU ()
Decision Date
May 2, 2008
Date Received
April 16, 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