IPC POWEREASE SYSTEM


Device Classification Name

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

510(k) Number K111520
Device Name IPC POWEREASE SYSTEM
Applicant
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Applicant Contact rishi sinha
Correspondent
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Correspodent Contact rishi sinha
Regulation Number 882.4310
Classification Product Code
HBE  
Subsequent Product Codes
GWF   HWE  
Date Received 06/02/2011
Decision Date 10/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls