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FDA 510(k) Application Details - K962939
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K962939
Device Name
Neurological Stereotaxic Instrument
Applicant
BRAINLAB, INC.
600 GLEN CT.
MOORESTOWN, NJ 08057 US
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Contact
STEFAN VILSMEIER
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
07/29/1996
Decision Date
05/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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