DAUM-LECTRIC MRI DRILLING MACHINE


Device Classification Name

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

510(k) Number K021098
Device Name DAUM-LECTRIC MRI DRILLING MACHINE
Original Applicant
MRI DEVICES DAUM GMBH
p.o. box 4331
crofton,, 
MD 
21114

Original Contact e. j smith
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 04/04/2002
Decision Date 12/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No