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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 K060808
Device Name BRAINPRO, BRAINPRO ACCESS
Applicant
Pajunk GmbH Medizintechnologie
Karl-Hall-Strasse 01
Geisingen,  DE 78187
Applicant Contact CHRISTIAN QUASS
Correspondent
Pajunk GmbH Medizintechnologie
Karl-Hall-Strasse 01
Geisingen,  DE 78187
Correspondent Contact CHRISTIAN QUASS
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/24/2006
Decision Date 07/25/2006
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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