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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 K981508
Device Name VECTORVISION SPINE MODULE
Applicant
Brainlab AG
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact STEFAN VILSMEIER
Correspondent
Brainlab AG
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact STEFAN VILSMEIER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/27/1998
Decision Date 10/29/1998
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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