MODIFICATION TO XPS 3000 SYSTEM


Device Classification Name

drill, surgical, ent (electric or pneumatic) including handpiece

510(k) Number K011321
Device Name MODIFICATION TO XPS 3000 SYSTEM
Original Applicant
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Original Contact martin d sargent
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 04/27/2001
Decision Date 06/26/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No