510(k) K864210

MICROSELECTRON-HDR (HIGH DOSE RATE) by Nucletron-Oldelft Corp. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1986
Date Received
October 28, 1986
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