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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 K003589
Device Name VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
Applicant
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Applicant Contact STEFAN VILSMEIER
Correspondent
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Correspondent Contact STEFAN VILSMEIER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/20/2000
Decision Date 05/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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