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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 K070556
Device Name BRAINSUITE NET
Applicant
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Applicant Contact RAINER BIRKENBACH
Correspondent
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Correspondent Contact RAINER BIRKENBACH
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
GCJ  
Date Received02/27/2007
Decision Date 09/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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