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FDA 510(k) Application Details - K072573
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K072573
Device Name
Neurological Stereotaxic Instrument
Applicant
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN 85622 DE
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Contact
BENJAMIN WAGNER
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/12/2007
Decision Date
10/11/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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