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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 K983410
Device Name @ TARGET
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  
Subsequent Product Code
KXK  
Date Received09/28/1998
Decision Date 09/17/1999
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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