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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K031770
Device Name CI TKR/UKR
Applicant
BRAINLAB, AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Applicant Contact RAINER BIRKENBACH
Correspondent
BRAINLAB, AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Correspondent Contact RAINER BIRKENBACH
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/09/2003
Decision Date 08/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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