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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 K092467
FOIA Releasable 510(k) K092467
Device Name VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
Applicant
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Applicant Contact ALEXANDER DRUSE
Correspondent
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Correspondent Contact ALEXANDER DRUSE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/12/2009
Decision Date 05/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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