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FDA 510(k) Application Details - K981508
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K981508
Device Name
Neurological Stereotaxic Instrument
Applicant
BRAINLAB, AG
3100 HANSEN WAY
PALO ALTO, CA 94304 US
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Contact
STEFAN VILSMEIER
Other 510(k) Applications for this Contact
Regulation Number
882.4560
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Classification Product Code
HAW
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More FDA Info for this Product Code
Date Received
04/27/1998
Decision Date
10/29/1998
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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