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FDA 510(k) Application Details - K983410
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K983410
Device Name
Neurological Stereotaxic Instrument
Applicant
BRAINLAB, AG
3100 HANSEN WAY
PALO ALTO, CA 94304 US
Other 510(k) Applications for this Company
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
09/28/1998
Decision Date
09/17/1999
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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