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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K021098
Device Name DAUM-LECTRIC MRI DRILLING MACHINE
Applicant
Mri Devices Daum GmbH
P.O. Box 4331
Crofton,,  MD  21114
Applicant Contact E. J SMITH
Correspondent
Mri Devices Daum GmbH
P.O. Box 4331
Crofton,,  MD  21114
Correspondent Contact E. J SMITH
Regulation Number874.4250
Classification Product Code
ERL  
Date Received04/04/2002
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
Predetermined Change
Control Plan Authorized		 No
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