XPS 3000 SYSTEM


definition

Device Classification Name

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

510(k) Number K002224
Device Name XPS 3000 SYSTEM
Original Applicant
MEDTRONIC XOMED
6743 southpoint dr. north
jacksonville, 
FL 
32216

Original Contact martin d sargent
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 07/24/2000
Decision Date 12/04/2000
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