510(k) K080871

TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS by Nucletron Corporation — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2008
Date Received
March 31, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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