MIDAS REX CURVED BUR


Device Classification Name

drills, burrs, trephines & accessories (simple, powered)

510(k) Number K072315
Device Name MIDAS REX CURVED BUR
Applicant
MEDTRONIC POWERED SURGICAL SOLUTIONS
4620 north beach st.
fort worth, 
TX 
76137

Applicant Contact jeffrey henderson
Correspondent
MEDTRONIC POWERED SURGICAL SOLUTIONS
4620 north beach st.
fort worth, 
TX 
76137

Correspodent Contact jeffrey henderson
Regulation Number 882.4310
Classification Product Code
HBE  
Subsequent Product Code
EQJ  
Date Received 08/20/2007
Decision Date 09/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No