510(k) K993400

HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

K993400 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 6, 2000. 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
January 6, 2000
Date Received
October 8, 1999
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