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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 K983831
Device Name VECTORVISION2
Applicant
Brainlab AG
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent
Brainlab AG
3100 Hansen Way
Palo Alto,  CA  94304
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/30/1998
Decision Date 05/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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