SODEM HIGH SPEED SYSTEM (PNEUMATIC)


Device Classification Name

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

510(k) Number K023070
Device Name SODEM HIGH SPEED SYSTEM (PNEUMATIC)
Original Applicant
SODEM SYSTEMS
110 ch. du pont du centenaire
geneva, 

CH

ch-1228

Original Contact carole burnier
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 09/16/2002
Decision Date 01/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No