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FDA 510(k) Application Details - K041330
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K041330
Device Name
Neurological Stereotaxic Instrument
Applicant
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN 85551 DE
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Contact
RAINER BIRKENBACH
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
05/19/2004
Decision Date
09/22/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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