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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, BADEN-WURTTEMBERG,  DE 78187
Applicant Contact CHRISTIAN QUASS
Correspondent
PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 01
GEISINGEN, BADEN-WURTTEMBERG,  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
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