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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 K010968
Device Name VECTORVISION CT/FLUORO
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 Received04/02/2001
Decision Date 08/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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