510(k) K170312

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools by Medtronic Powered Surgical Solutions — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2017
Date Received
February 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type