510(k) K063381

CT COMPATIBLE F/S/D APPLICATORS by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

K063381 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "CT COMPATIBLE F/S/D APPLICATORS". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2006
Date Received
November 8, 2006
Clearance Type
Traditional
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