510(k) K072315

MIDAS REX CURVED BUR by Medtronic Powered Surgical Solutions — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2007
Date Received
August 20, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type